Today's News and Commentary

National Health Expenditure Projections, 2022-2031
Health Affairs periodically updates expenditure projections and provides an analysis for them.
Read this article in its entirety.

About health insurance/insurers

Appeals court grants partial stay in ACA preventive care case “A panel of judges at the Fifth Circuit Court of Appeals issued a stay Tuesday that partially halts a lower court ruling striking down the mandate. As part of the order, the Biden administration can continue to enforce the preventive service mandate nationwide aside from against the case's named plaintiffs.”

Medicare Advantage Enrolls Lower-Spending People, Leading to Large Overpayments Key Takeaways

  • Beneficiaries with lower-than-average expenditures than those with similar risk factors were significantly more likely to switch from Fee-for-Service (FFS) to Medicare Advantage (MA).

  • As a result, risk-score-adjusted expenditures for the 16.9 million beneficiaries who switched from FFS to MA between 2006–2019 were substantially below average. Plans were overpaid because MA rates are intended for beneficiaries with average—not systematically below average—expenditures.

  • MA plans in 2020 were overpaid by 14.4% due to this favorable selection phenomenon; when combined with the 6% overpayment reported by MedPAC for coding intensity and other factors, total MA overpayments were on the order of 20%.

  • Basing MA payment benchmarks on FFS expenditures is increasingly problematic as FFS enrollment continues to decline – underscoring the need for reforming how MA payments are set such as by decoupling MA payments from FFS benchmarks or instituting competitive bidding.”

Bottom line is that overpayments in MA could top $75 billion in 2023, or 20%.

Older adults are finally catching up on delayed surgeries. That means pain for health insurers, gains for hospital operators. “The trend was revealed by executives at Dow component UnitedHealth Group Inc. at a Goldman Sachs investor conference held on Tuesday. The revelation dented UnitedHealth shares by 5.6% in premarket trade, while shares of rivals also saw steep declines. Humana Inc. shares dropped 8% premarket, while Elevance Health Inc. shares dropped 4.8% and Cigna Group fell 4%.
Shares of hospital and surgical-center operators, meanwhile, profited from insurers’ pain. Shares of Surgery Partners Inc. , an operator of surgical facilities and related services, gained 7.4% premarket, while shares of hospital operator Community Health Systems Inc. jumped more than 10% and shares of hospital giant HCA Healthcare Inc. gained 3%.”

About hospitals and healthcare systems

 No nonprofit health systems downgraded in May, S&P Global says “While there were some outlook revisions, no nonprofit healthcare system was downgraded in May, the first time that has happened since October 2021, S&P Global said.
There were also three upgrades during the month on two health systems and one standalone hospital, the ratings agency said. Two of those ratings were due to the strength of the newly consolidated Charlotte, N.C.-based Advocate Health following the combination of Downers Grove, Ill., and Milwaukee-based Advocate Aurora Health and Charlotte-based Atrium Health, according to S&P Global.”

About pharma

 Pfizer expects to run out of some antibiotic supply for children soon “Supply of the pediatric version of the drug, Bicillin L-A, is expected to be exhausted by the end of this quarter, the company said in a letter to the U.S. health regulator dated Monday. Pfizer said in an email on Tuesday that the pediatric formulations of the antibiotic are not widely used.”

Top 20 Most Commonly Prescribed Medications FYI

About the public’s health

 Racial, Ethnic, and Socioeconomic Differences in Food Allergies in the US “In this survey study of 51 819 households, Asian, Black, and Hispanic individuals were more likely to report having food allergies compared with White individuals. The prevalence of food allergies was lowest among households in the highest income bracket.”

About healthcare personnel

 Demand for behavioral health services outstrips supply of providers, driving higher costs, analysis finds “In the first year of the pandemic, the global prevalence of anxiety and depression increased by a massive 25%, according to research from the World Health Organization. The pandemic also catalyzed investments in digital health capabilities, such as expanding virtual therapy and e-prescribing, in response to unprecedented demand.
Despite increased awareness and attention to behavioral health challenges, there continues to be a shortage of mental health providers. According to data from the Kaiser Family Foundation, 47% of the U.S. population in 2022 was living in a mental health workforce shortage area, with some states requiring up to 700 more practitioners to remove this designation.”

Comparison of Work Patterns Between Physicians and Advanced Practice Practitioners in Primary Care and Specialty Practice Settings Question  How do work patterns of physicians and advanced practice practitioners (APPs; ie, nurse practitioners and physician assistants) vary by specialty?
Findings  In this cross-sectional study of 217 924 clinicians, medical and surgical specialty physicians saw 6.7 and 7.4 percentage points more new patient visits, respectively, than their APP counterparts, whereas primary care physicians saw 2.8 percentage points fewer new patient visits compared with APPs. Medical and surgical physicians spent 34.3 and 45.8 fewer minutes per day, respectively, using the electronic health record than did APPs in their specialties, whereas primary care physicians spent 17.7 more minutes per day than did APPs.”

About health technology

 Federal advisory group rejects proposal to make medical device tracking easier “Every medical device has its own unique code, allowing manufacturers to keep track of their products once they enter the market. But while these codes are critical for recalling faulty devices or issuing updates, they rarely make their way into health records.
For years, experts have argued for a simple fix: adding device identifiers to insurance claims forms, which doctors use to request reimbursement for medical services. That, they say, would make it easier to reach patients at risk of flawed devices, and allow long-term study of device efficacy, safety, and cost.
But the idea is being held up by the slow-moving process of updating Medicare claims forms. It suffered another setback on Wednesday when the National Committee on Vital and Health Statistics, a group that advises the federal health department, voted not to recommend a slew of updates to claims forms — including the device identifier addition.”

Today's News and Commentary

About Covid-19

 COVID shots should target XBB variants in 2023-24 campaign, US FDA staff say “COVID-19 vaccines being developed and manufactured for the 2023-2024 campaign should target one of the currently dominant XBB variants, the U.S. Food and Drug Administration's (FDA) staff reviewers said on Monday.
The comments were made in documents posted ahead of Thursday's meeting of a panel of FDA's independent experts, who are expected to make recommendations on what strain an updated COVID-19 booster should target.”

About health insurance/insurers

Medicaid Enrollment and Unwinding Tracker “At least 1,027,000 Medicaid enrollees have been disenrolled as of June 12, 2023, based on the most current data from 20 states. Another 1.5 million enrollees had their coverage renewed, though four of the 20 reporting states do not provide data on renewed enrollees. At least 2.5 million total renewals were completed across the 20 states. However, these data undercount the actual number of disenrollments because not all states have publicly available data on total disenrollments.
The median disenrollment rate is 40%, but there is wide variation across states ranging from 12% in Nebraska to 73% in Idaho.”
In a related piece: Letter to U.S. Governors from HHS Secretary Xavier Becerra on Medicaid Redeterminations “Given the high number of people losing coverage due to administrative processes, I urge you to review your state’s currently elected flexibilities and consider going further to take up existing and new policy options that we have offered to protect eligible individuals and families from procedural termination.  I am pleased to announce several new options for states to consider adopting, such as allowing states to use their managed care plans to help beneficiaries complete these forms.  These new options build on existing flexibilities we have already offered states, such as:

  • Spreading renewals for all populations out over 12 months, which will provide more time to run a smooth process and prevent systems from getting backlogged.  A smooth process reduces burden not only on individuals and families, but also on state eligibility systems. Taking the time to do the process correctly will ensure those eligible for continued coverage do not experience a gap in care and those no longer eligible easily transition to other sources of coverage.

  • Maximizing the use of data sources, such as renewing individuals on the basis of their eligibility for other programs, such as the Supplemental Nutrition Assistance Program (SNAP) or Temporary Assistance for Needy Families (TANF).  This will help reduce the need for some individuals to fill out and return a Medicaid renewal form.

  • Partnering with managed care plans and using data available from the United States Postal Service to update people’s contact information so that they actually receive the renewal forms states are sending out.

These are just a few of the options that help to maintain coverage for eligible people – there are many more, and we welcome the opportunity to provide technical assistance to implement these policies.
A full list of available state strategies is available here.

Health Care Affordability Improved Between 2019 and 2022 Under Pandemic Health Coverage Policies “The share of adults reporting difficulty paying medical bills decreased from 18.7 percent to 15 percent from 2019 to 2022. The share of adults who reported forgoing needed medical care due to cost in the past year declined by more than 4.5 percent (18.5% to 13.9%). The share of Black and Hispanic adults reporting difficulty paying medical bills and forgoing needed medical care due to its cost fell sharply, reaching rates closer to those of White adults by 2022.”

CMS grows outreach of Part D Extra Help program ahead of 2024 expansion “The feds expanded eligibility for the Extra Help program as part of the Inflation Reduction Act, effective Jan. 1, 2024. Under the law, Medicare beneficiaries with limited resources and incomes of up to 150% of the federal poverty level can sign up for the full low-income subsidy.
That subsidy can be used to pay for Part D premiums as well as cost-sharing for medications. The Department of Health and Human Services (HHS) said in a fact sheet that 300,000 people currently enrolled in the program stand to benefit from the expansion, and they could save nearly $300 per year on average.
HHS estimates that up to 3 million seniors and people with disabilities could stand to benefit from Extra Help but are not currently enrolled."

Compromise struck to preserve Obamacare’s preventive care mandate “The agreement, which still needs approval from the 5th U.S. Circuit Court of Appeals, keeps coverage intact nationwide while the case proceeds. The Biden administration, in exchange, pledged not to enforce the mandate to cover HIV prevention drugs and other preventive care services against the employers and individual workers who sued claiming that doing so violated their religious beliefs. This means that even if the Affordable Care Act rules are upheld on appeal, the government can’t penalize the challengers for refusing to cover required services.”

About pharma

 Not covering emerging Alzheimer's drugs could cost Medicare billions: study “Emerging Alzheimer’s disease medications come with high price tags, but researchers with the University of Chicago calculate that in the long run, it’s much less costly to cover these therapies for Medicare beneficiaries.
Providing coverage for these drugs would save the public payers between $13.1 billion and $545.6 billion in healthcare costs over the course of 17 years, according to the white paper…
Part of the additional costs under CMS’ current policy would stem from an increase in private and public healthcare spending by $6.8 billion to $284.5 billion, according to the study.
’For Medicare, the value lost ranges from $3.1 billion to $128 billion for CMS delay of 0 to 17 years, and for Medicaid the range is $1.3 billion to $54.1 billion,’ the white paper said. ‘Combining Medicare and Medicaid, the value lost to public insurance would range from $4.4 billion to $182.1 billion.’”
And in a related story: European Alzheimer's experts unconvinced by new Eisai, Biogen drug “Alzheimer's disease experts in Europe weighing potential use of a new drug from Eisai and Biogen say its ability to slow cognitive decline may not outweigh its health risks, or be worth the toll on scarce healthcare resources.”

Sanders vows to oppose NIH nominee until Biden produces drug-pricing plan “Sen. Bernie Sanders (I-Vt.), chairman of the Senate health panel, is vowing to not move forward with President Biden’s nominee to lead the National Institutes of Health — or any health nominee — until he receives the administration’s ‘comprehensive’ plan on lowering drug prices.”

Some Cancer Patients Must Travel Hundreds of Miles for Medication “Health emergency’s end means independent cancer doctors can’t send prescriptions directly to their Medicare patients…
The Centers for Medicare and Medicaid Services in September 2021 posted a list of frequently asked questions that said independent oncologists can dispense prescriptions only to a patient who is physically in the doctor’s office at the time. 
Sending oral chemotherapy drugs by mail violates the Stark law, the agency said. The law bans doctors from making referrals of Medicare and Medicaid patients to other organizations or medical businesses where they have a financial stake. The restriction also applies to other independent practices, such as urology, that have an on-site dispensing pharmacy.”
These excuses for why patients need to get their medication from physicians’ offices seems specious: “But oncologists say that allowing Medicare patients to get cancer drugs from third-party specialty pharmacies doesn’t solve the problem, leads to waste and drives up costs. The pharmacies, they say, are often run by pharmacy-benefit managers that have lately been under fire from congressional lawmakers who assert they drive up prices. [Comment: But patients may pay more for drugs with PBMs. The article does not compare physician dispensed prices agains those obtained through the Part D plan.]
Many such pharmacies provide 90-day prescriptions, they say, and cancer patients often need shorter prescriptions because their treatment may change frequently in response to how a patient is responding. [Comment: PBMs can furnish any amount the physician orders. Also, the article did not say how many of these patients could not get these drugs from a local pharmacy. Nor did it comment on the fact that physicians were making a nice profit on selling these drugs.]
In a related article: Cancer drug shortage is complicating treatment, survey findsThe ongoing shortages of numerous oncology medications are causing delays in care for patients at cancer centers, according to a study from the National Comprehensive Cancer Network.”

About the public’s health

Reduced Stress-Related Neural Network Activity Mediates the Effect of Alcohol on Cardiovascular Risk “Chronic stress associates with major adverse cardiovascular events (MACE) via increased stress-related neural network activity (SNA). Light/moderate alcohol consumption (ACl/m) has been linked to lower MACE risk, but the mechanisms are unclear…
ACl/m associates with reduced MACE risk, in part, by lowering activity of an stress-related brain network known for its association with cardiovascular disease. Given alcohol’s potential health detriments, new interventions with similar effects on SNA are needed.”

 Brain responses to nutrients are severely impaired and not reversed by weight loss in humans with obesity: a randomized crossover study “We show that intragastric glucose and lipid infusions induce orosensory-independent and preference-independent, nutrient-specific cerebral neuronal activity and striatal dopamine release in lean participants. In contrast, participants with obesity have severely impaired brain responses to post-ingestive nutrients. Importantly, the impaired neuronal responses are not restored after diet-induced weight loss. Impaired neuronal responses to nutritional signals may contribute to overeating and obesity, and ongoing resistance to post-ingestive nutrient signals after significant weight loss may in part explain the high rate of weight regain after successful weight loss.”
Comment: The article title is more understandable than the Abstract excerpt. What is important is that this study contributes to the literature that obesity has physiologic causes beyond behavioral ones.

AMA asks doctors to de-emphasize use of BMI in gauging health and obesity “A subcommittee of the AMA wrote in a report leading up to the vote that BMI doesn’t differentiate between fat and lean mass and doesn’t account for body fat location. Studies have shown that fat that accumulates around the abdomen may be more dangerous than fat that gathers in the legs and thighs, hence why waist circumference or the waist-to-hip ratio could be useful measurements.
Additionally, BMI cutoffs don’t appropriately represent risks across racial groups, the subcommittee wrote. For example studies have shown that Asian, Hispanic and Black people have a higher risk of developing type 2 diabetes at lower BMIs than white people.”

About healthcare IT

 Suicide hotlines promise anonymity. Dozens of their websites send sensitive data to Facebook Great piece of investigative journalism. “Websites for mental health crisis resources across the country — which promise anonymity for visitors, many of whom are at a desperate moment in their lives — have been quietly sending sensitive visitor data to Facebook, The Markup has found.”

About healthcare personnel

 29 physician specialties ranked by student debt burden “ The emergency medicine specialty has the highest percentage of physicians who are still paying off student debt, according to Medscape's ‘Physician Wealth & Debt Report’ published June 9.”
Comment: Post medical school debt is said to be one factor in specialty choice; however, this list does not seem to correlate low debt with higher paying specialties. For example, Plastic and General Surgery both have scores of 23% while Diabetes and endocrinology come is at 11 percent.

Today's News and Commentary

About Covid-19

Outpatient treatment of COVID-19 and incidence of post-COVID-19 condition over 10 months (COVID-OUT): a multicentre, randomised, quadruple-blind, parallel-group, phase 3 trial “Outpatient treatment with metformin reduced long COVID incidence by about 41%, with an absolute reduction of 4·1%, compared with placebo. Metformin has clinical benefits when used as outpatient treatment for COVID-19 and is globally available, low-cost, and safe.”
Comment: I did not find the words “side effect” or “complication” in a word search of the article.

The Great Grift: How billions in COVID-19 relief aid was stolen or wasted Due to inadequate oversite: “An Associated Press analysis found that fraudsters potentially stole more than $280 billion in COVID-19 relief funding; another $123 billion was wasted or misspent. Combined, the loss represents 10% of the $4.2 trillion the U.S. government has so far disbursed in COVID relief aid.
That number is certain to grow as investigators dig deeper into thousands of potential schemes.”
Great piece of investigative reporting.

About health insurance/insurers

Primary Care Spending in the US Population “Primary care spending in 2019 totaled $439 per person. Spending was highest for the Medicare population ($736) and lowest for the uninsured population ($78); spending was $461 for those with group private insurance.
The percentage of medical spending on primary care was 7.0% for the population and was lower for those 65 years or older (5.1%), those in worse health (5.6%), and those with Medicare (5.3%). Nearly 41% of the population had 0 primary care spending. This percentage was higher for Hispanic (52.7%), non-Hispanic Black (49.0%), and non-Hispanic other (44.3%) individuals and 79.9% for uninsured individuals... 
Primary care spending varied significantly by insurance type and area.”

About hospitals and healthcare systems

Intermountain Health has 'AA+' ratings affirmed, highest in nonprofit healthcare Salt Lake City-based Intermountain Health had an "AA+" rating on several bonds affirmed as the 33-hospital system continues to enjoy a strong financial profile and relatively low debt, S&P Global said June 8.
Such ratings are the highest in the U.S. nonprofit healthcare sector, the report said. Intermountain Health also had an "AA" rating assigned on 2019 bonds, and the outlook for all such debt is stable.”

About pharma

 Governments get nearly $19 billion more in opioid lawsuit settlements “States and local governments will receive an additional $18.75 billion from pharmacy chains and drug manufacturers to settle lawsuits over their roles in flooding the country with painkillers — money meant to help communities still grappling with an unparalleled addiction and overdose crisis, attorneys announced Friday.
The settlements are to be paid by drug manufacturers Allergan and Teva, plus CVS and Walgreens. The settlements also include Walmart, which is expected to finalize its deal shortly.
The agreements emerge more than a year after pharmaceutical company Johnson & Johnson, along with drug distributors AmerisourceBergen, Cardinal Health and McKesson, agreed to pay about $26 billion to settle. In total, more than $50 billion has been allocated to settle waves of lawsuits meant to hold accountable companies that failed to stop the flow and abuse of prescription pills in the 2000s and 2010s.”

US Chamber of Commerce sues over government's drug pricing power “In a complaint filed in federal court in Dayton, Ohio, the chamber said the pricing program violated drugmakers' due process rights under the U.S. Constitution by giving the government ‘unfettered discretion’ to dictate maximum prices.
It also said the program would impose exorbitant penalties on drugmakers that don't accept those prices, and amounted to an ultimatum: agree to whatever price the government names, or we'll smash up your business.’”
Comment: This action reveals the dilemma of this organization. It doesn’t want government interfering with business; however, this governmental program would lower healthcare costs that these same firms find so expensive.
In a related article: U.S. government sets penalties on 43 drugs over price hikes “The Biden administration on Friday announced it would impose inflation penalties on 43 drugs for the third quarter of 2023, having fined 27 earlier this year, in a move it said would lower costs for older Americans by as much as $449 per dose.
Drugmakers hiked the price of these 43 drugs by more than the rate of inflation and are required to pay the difference of those medicines to Medicare, the federal health program for Americans over age 65.”

Use of Non-Psychiatric Medications With Potential Depressive Symptom Side Effects and Level of Depressive Symptoms in Major Depressive Disorder [MDD] “Individuals treated for MDD frequently use non-psychiatric medications for comorbid medical conditions that are associated with an increased risk of depressive symptoms. In evaluating the response to antidepressant medication treatment, side effects of concomitantly used medications should be considered.”

Walgreens sells remaining stake in Option Care Health for $330M in latest divestiture move “The drugstore chain announced Thursday it sold 10.8 million shares of Option Care Health and plans to use the proceeds primarily for debt paydown, continued support of the company's strategic priorities and to help fund its healthcare-focused business initiatives, according to a press release.”

Novartis inks $3.2B Chinook buyout to lift kidney disease plan “While working to generate phase 3 data on its own IgA nephropathy candidate, the Swiss drugmaker has seized the chance to buy Chinook Therapeutics for a pair of late-stage programs targeting the rare, progressive chronic kidney disease.
Chinook has accepted a buyout bid worth $3.2 billion upfront, plus $300 million payable if it hits certain regulatory milestones.” 

About healthcare personnel

HHS Announces New $15 Million Loan Repayment Program to Strengthen the Pediatric Health Care Workforce The “U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), launched the new Pediatric Specialty Loan Repayment Program, a $15 million investment to recruit and retain clinicians who provide health care to children and adolescents.
In exchange for three years of service working in a health professional shortage area, medically underserved area, or providing care to a medically underserved population, the Pediatric Specialty Loan Repayment Program provides up to $100,000 to eligible clinicians providing pediatric medical subspecialty, pediatric surgical specialty, or child and adolescent behavioral health care, including substance use prevention and treatment services.”

 Early 2023 healthcare wage inflation eases “Early 2023 data is showing that healthcare labor costs are subsiding compared to 2021 and 2022, according to a new report from credit ratings agency Fitch.
Despite the good news for hospitals, the 2023 average hourly earnings growth of 4.7 percent still outpaces the 2.4 percent average increase in hourly pay for healthcare workers from 2010 to 2019. 
Fitch attributed the jump in earnings to the conversion of contract labor to full-time workers, according to the June 12 report.”

Today's News and Commentary

About Covid-19

 White House COVID czar Ashish Jha stepping down “White House COVID-19 response coordinator Ashish Jha is stepping down from his position on June 15 to return to his previous role as dean of the Brown University School of Public Health…
Jha's role will be replaced by the newly created Office of Pandemic Preparedness and Response, which currently has no leader and no staff.”

Safety Monitoring of mRNA COVID-19 Vaccine Third Doses Among Children Aged 6 Months–5 Years — United States, June 17, 2022–May 7, 2023
What is already known about this topic?
All children aged 6 months–5 years are recommended to receive ≥1 bivalent mRNA COVID-19 vaccine dose; approximately 550,000 children in these age groups have received a third monovalent or bivalent mRNA vaccine dose.
What is added by this report?
In v-safe, 38% of children had no reported reactions after a third dose; most reported reactions were mild and transient. Vaccination errors accounted for 78% of events reported to the Vaccine Adverse Event Reporting System.
What are the implications for public health practice?
Findings after receipt of a third mRNA vaccine dose among young children were similar to those described after receipt of 1 and 2 doses; no new safety concerns were identified.”

About health insurance/insurers

CMS announces new decade-long primary care payment experiment How it works: The Centers for Medicare and Medicaid Services envisions running Making Care Primary between July 1, 2024, and December 31, 2034.

  • It's designed to draw providers with little or no experience in value-based care.

  • Participants will receive enhanced payment and tools from CMS to coordinate care with specialists and support care integration.

  • CMS will test the program in Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington. Provider applications open later this summer.”

Here are more details from CMS:
MCP’s three progressive tracks are designed to recognize participants’ varying experience in value-based care—from under-resourced participants to those with existing advanced primary care experience in alternative payment models. MCP aims to give these organizations flexibility, allowing them to choose their participation track and receive payments that reflect each participant’s experience towards accountable care. Again, MCP is a three-track model with one track reserved for organizations with no prior value-based care experience. 

  • Track 1 –Building Infrastructure: Participants will begin to develop the foundation for implementing advanced primary care services such as risk-stratifying their population, reviewing data, building out workflows, identifying staff for chronic disease management, and conducting health-related social needs screening and referral. Payment for primary care will remain fee-for-service (FFS), while CMS provides additional financial support to help participants develop care transformation infrastructure and build advanced care delivery capabilities. Participants can begin earning financial rewards for improving patient health outcomes in this track.

  • Track 2 – Implementing Advanced Primary Care: As participants progress to Track 2, they will build upon the Track 1 requirements by partnering with social service providers and specialists, implementing care management services, and systematically screening for behavioral health conditions. Payment for primary care will shift to a 50/50 blend of prospective, population-based payments and FFS payments. CMS will continue to provide additional financial support at a lower level than Track 1, as participants continue to build advanced care delivery capabilities. Participants will be able to earn increased financial rewards for improving patient health outcomes. 

  • Track 3 – Optimizing Care and Partnerships: In Track 3, participants will expand upon the requirements of Tracks 1 and 2 by using quality improvement frameworks to optimize and improve workflows, address silos to improve care integration, develop social services and specialty care partnerships, and deepen connections to community resources. Payment for primary care will shift to fully prospective, population-based payment while CMS will continue to provide additional financial support, at a lower level than Track 2, to sustain care delivery activities while participants have the opportunity to earn greater financial rewards for improving patient”

Comment: Look at the payment systems. It appears that Track 1 is fee-for-service (FFS) with incentives. The exact population-based payment mechanisms for Tracks 2 and 3 are unclear. Is it capitation or a different kind of FFS? Research has shown that if providers do not have downside risk, the desired behaviors are unlikely to occur. Further, if ACOs are any indication, providers are reluctant to assume risk, in this case, it might mean going into Step 3. Additionally, the country has a shortage of primary care physicians (PCPs), particularly if you remove hospitalists (many of whom are internists and pediatricians) from the equation. Finally, a 5 or 10% increase for primary care physicians does not put them anywhere near the ballpark of procedural or imaging practitioners, e.g., surgeons and radiologists, respectively. In other words, it will not provide enough of an incentive to recruit PCPs from medical school.
So…is this program “old wine in new bottles?” let’s wait to see how it plays out.

The Facts About Medicare Spending A must read from the KFF.

 Supreme Court upholds right to sue public nursing homes The Supreme Court upheld an individual right to sue public nursing homes for violated rights protected under a federal law that sets standards for these institutions. 
The court affirmed an appeals court ruling in a 7-2 decision that found a private individual can sue for rights protected by the Federal Nursing Home Reform Act through Section 1983 of the federal code, which allows someone to sue for their federal civil rights.”

About hospitals and healthcare systems

Top 100 critical access hospitals, state by state FYI.

About pharma

 FDA panel unanimously endorses Leqembi for full approval “An FDA advisory panel has voted 6-0 in favour of recommending that Eisai and Biogen's Alzheimer's drug Leqembi be granted full approval. The drug secured accelerated approval back in January based on Phase II results indicating that it helped reduce amyloid plaques in the brain, with the committee meeting on Friday to discuss whether that should be converted to a traditional nod in light of the Phase III Clarity AD trial, which showed that it slowed cognitive decline in early Alzheimer's patients by 27% versus placebo.”
Comment: Now comes the real controversy—figuring out how to pay for it.

About the public’s health

F.D.A. Panel Recommends R.S.V. Shot to Protect Infants “A Food and Drug Administration advisory panel recommended approval of a monoclonal antibody shot aimed at preventing a potentially lethal pathogen, respiratory syncytial virus, or R.S.V., in infants and vulnerable toddlers…
The 21-member panel voted unanimously in favor of giving the treatment to infants born during or entering their first R.S.V. season. The advisers voted 19-2 for giving the shot to children up to 24 months of age who remain vulnerable to severe disease.”

The 2023 nonhormone therapy position statement of The North American Menopause Society “Evidence-based review of the literature resulted in several nonhormone options for the treatment of vasomotor symptoms. Recommended: Cognitive-behavioral therapy, clinical hypnosis, selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors, gabapentin, fezolinetant (Level I); oxybutynin (Levels I-II); weight loss, stellate ganglion block (Levels II-III). Not recommended: Paced respiration (Level I); supplements/herbal remedies (Levels I-II); cooling techniques, avoiding triggers, exercise, yoga, mindfulness-based intervention, relaxation, suvorexant, soy foods and soy extracts, soy metabolite equol, cannabinoids, acupuncture, calibration of neural oscillations (Level II); chiropractic interventions, clonidine; (Levels I-III); dietary modification and pregabalin (Level III).”

HHS Releases First-Ever STI Federal Implementation Plan Thursday, “the U.S. Department of Health and Human Services (HHS) released the STI Federal Implementation Plan to detail how various agencies and departments across the federal government are taking a comprehensive approach to making meaningful and substantive progress in improving public health…
The STI Federal Implementation Plan highlights more than 200 actions that federal stakeholders will take to achieve its five goals:
Goal 1: Prevent New STIs
Goal 2: Improve the Health of People by Reducing Adverse Outcomes of STIs
Goal 3: Accelerate Progress in STI Research, Technology, and Innovation
Goal 4: Reduce STI-Related Health Disparities and Health Inequities
Goal 5: Achieve Integrated, Coordinated Efforts That Address the STI Epidemic”

PEPFAR at 20—Looking Back and Looking Ahead “In his State of the Union Address on January 28, 2003, President Bush announced the creation of the United States President’s Emergency Plan for AIDS Relief (PEPFAR)—with $15 billion provided over a 5-year plan to combat AIDS in the countries with the greatest disease burden…
By any global health metric, PEPFAR has surpassed every milestone imagined. More than 25 million lives have been saved, 5.5 million infants have been born HIV-free, and today more than 75% of the 38.4 million people living with HIV/AIDS globally are taking ART. Wide-scale treatment has also meant that annual transmission rates have dropped by 52% since 2010, largely attributable to durable viral suppression preventing onward transmission, demonstrating the impact of treatment as prevention.”
Read the article to understand where the program goes from here.

Today's News and Commentary

About health insurance/insurers

Fitch: Large payer finances stable, but pressures mounting in 2023 “Three notes:
—For the seven largest payers, revenues increased 10.5 percent in the first quarter year over year. Profits rose 7.7 percent in the first quarter compared to 7.6 percent during the same period in 2022.
—Large, geographically diverse payers are seeing stable performances, while less diversified insurers are more varied and subject to local market conditions.
—Financial leverage for large insurers increased to 43 percent in the first quarter, compared to 41 percent year over year, or an increase of 11 percent in outstanding debt to $167 billion.”

SCAN, CareOregon fund $110M in medical debt relief “SCAN Group and CareOregon have issued grants to RIP Medical Debt that will wipe out millions in patients' medical debt.
The two nonprofit insurers, which are in the midst of merging, will together donate $345,000 to the organization, funding debt relief for 67,000 people across Arizona, California, Nevada, Oregon and Texas, where the health plans operate, according to an announcement issued Wednesday morning.
The grant will abolish $110 million in medical debt, and all of the beneficiaries have incomes that are at or below 400% of the federal poverty level, or their debt represents 5% or more of their household income.”

About hospitals and healthcare facilities

BREAKING: Justices Allow Private Suits Under Fed. Nursing Home LawThe U.S. Supreme Court on Thursday ruled that a nursing home resident does indeed have a private right of action under the Federal Nursing Home Reform Act, in a suit accusing an Indiana care facility of negligently giving a resident psychotropic drugs and trying to transfer him without family consent.” 

Nonprofit Hospitals: Profits And Cash Reserves Grow, Charity Care Does Not “Mean hospital profits grew from 2012 to 2019, but this increase was not associated with the provision of more charity care by nonprofit hospitals, even though their cash reserve balances increased. In contrast, although charity care is not required for for-profit hospitals, an increase in profit was associated with an increase in charity care for them; this may be because spending on charity care is tax deductible.”

About pharma

 US Military Is So Worried About Drug Safety It Wants to Test Widely Used Medicines “Defense officials are in talks with Valisure, an independent lab, to test the quality and safety of generic drugs it purchases for millions of military members and their families, according to several people familiar with the matter who asked not to be named as the details aren’t public.”

About the public’s health

 Given the Canadian fires, check this site for an update on the air quality in your zip code.

Today's News and Commentary

Book Recommendation:
Jellyfish Age Backwards: Nature’s Secrets to Longevity by Nicklas Brendborg
A very well-written, evidence-based book about the science and possible “treatments” of aging.

About Covid-19

 Moderna, Pfizer hit with new patent lawsuits over COVID vaccines 

  • “Promosome sued Moderna, Pfizer and BioNTech in federal court in San Diego on Tuesday, accusing their COVID-19 vaccines of infringing a patent related to mRNA technology, as reported in Fidelity.

  • The biotech firm accused the companies of copying technology that allows for doses of mRNA that are small enough to use safely and effectively in the vaccines. It is asking the court for a share of royalties from the shots.

  • Pfizer earned $37.8 billion from sales of its BioNTech-partnered COVID-19 vaccine Comirnaty last year, while Moderna made $18.4 billion from its vaccine Spikevax.

  • Promosome said its technology enables the immune system to produce sufficient proteins to fight the virus with small doses of mRNA.

  • The lawsuits claim Promosome met with Moderna between 2013 and 2016 to discuss licensing the technology and that Promosome's president demonstrated it to a senior BioNTech scientist in 2015, although it said neither company agreed to a license.”

About health insurance/insurers

 Health Insurance Coverage and Postpartum Outcomes in the US  The presence of insurance does not always improve health: “The findings of this systematic review suggest that evidence evaluating insurance coverage and postpartum visit attendance and unplanned care utilization is, at best, of moderate SoE [Strength of evidence]. Future research should evaluate clinical outcomes associated with more comprehensive insurance coverage.”

Humana opens 250th primary care center as it continues to focus on growth “The Medicare Advantage giant has established a multiyear effort to continue scaling CenterWell and expects to open between 30 and 50 centers per year through 2025. In addition to the senior-focused primary care clinics, CenterWell also houses Humana's home health business, another key strategic focus, and is sister to the Conviva Care Center brand.
Collectively, Humana's Primary Care Organization cares for 266,000 seniors across its markets.”

Judge certifies class action in Aetna, Optum 'dummy code' lawsuit “A federal judge in North Carolina certified class action status June 5 in a lawsuit alleging Aetna and OptumHealth Care Solutions conspired to use "dummy code" to make administrative fees appear to be billable medical charges.
The lawsuit, which was originally filed in 2015, alleges the two insurers tricked plaintiff Sandra Peters, other patients similarly situated and their employers into paying administrative fees by disguising them as medical expenses. The lawsuit alleges the defendants violated the Employee Retirement Income Security Act.”

About hospitals and healthcare systems

Racial, Ethnic, and Payer Disparities in Adverse Safety Events: Are there Differences across Leapfrog Hospital Safety Grades? The highlights are on page 6 and are as you would expect; however, this finding was a bit of a surprise:
”Relative to privately insured patients, Medicare patients averaged significantly higher rates of adverse safety events on 10 of 11 PSIs [patient safety indicators]and statistically similar rates on 1 PSI. Relative to privately insured patients, Medicaid patients had significantly higher rates of adverse safety events on 8 of 11 PSIs and statistically similar rates on the remaining 3 PSIs. Again, we observed little pattern between a hospital’s overall letter grade and the size of the difference in adverse safety events between patients with Medicare or Medicaid coverage and those with private insurance.”

About the public’s health

 U.S. Gun Violence in 2021 [Published June, 2023] “In 2021, for the second straight year, gun deaths reached the highest number ever recorded. Nearly 49,000 people died from gun violence in the U.S. in 2021. Each day, an average of 134 people died from gun violence—one death every 11 minutes.
Gun homicides continued to rise in 2021, increasing 7.6% over the previous year. Gun suicides reached record levels, increasing 8.3%, the largest one-year increase recorded in over four decades. Guns, once again, were the leading cause of death among children and teens in 2021 accounting for more deaths than COVID-19, car crashes, or cancers.”

Today's News and Commentary

About healthcare quality

The Volume and Cost of Quality Metric Reporting “Preparing and reporting data for 162 unique quality metrics required an estimated 108 478 person-hours, costing an estimated $5 038 218.28 (2022 USD) in personnel costs plus an additional $602 730.66 in vendor fees. Claims-based and chart-abstracted metrics used the most resources per metric, while electronic metrics consumed far less.”

About health insurance/insurers

 Appeals court to hear arguments about ObamaCare preventive coverage A federal appeals court will hear arguments Tuesday about whether to continue a pause of a Texas district court’s ruling that struck down an ObamaCare provision requiring insurers to cover preventive services for free.
Last month, the U.S. Court of Appeals for the 5th Circuit temporarily paused Judge Reed O’Connor’s decision until a panel could hear oral arguments on whether the pause should be continued during the appeals process.”

About hospitals and healthcare systems

 Capital Costs Rise For Critical-Access, Acute-Care Hospitals, Analysis Indicates “‘In a Modern Healthcare analysis of cost reports for hospitals filing from 2018 through 2022, median net capital costs for critical-access hospitals increased almost 17%, while those for acute-care hospitals rose only 1% over the same period.’ Meanwhile, ‘overall operating expenses for critical-access hospitals and acute-care hospitals increased at a faster rate than capital costs over the same period.’” 

About pharma

Merck sues US government to halt Medicare drug price negotiation “Merck & Co sued the U.S. government on Tuesday, seeking to halt the Medicare drug price negotiation program contained in the Inflation Reduction Act (IRA), which it argues violates the Fifth and First Amendments to the U.S. Constitution.
This is the first attempt by a drugmaker to challenge the law, which the pharmaceutical industry says will result in a loss of profits that will force them to pull back on developing groundbreaking new treatments.”

About health technology

 Illumina appeals FTC order to divest cancer test maker Grail “Illumina on Monday filed an appeal against a Federal Trade Commission (FTC) order, demanding that it divest cancer diagnostic test maker Grail over competition concerns in the U.S. market for cancer tests.”

Today's News and Commentary

About Covid-19

 HHS finalizes end of COVID-19 vaccination rule for hospitals “The federal government is formally withdrawing the COVID-19 vaccine mandate for employees of CMS-certified healthcare facilities that was enacted in November 2021 and moving to treat the virus, from an oversight standpoint, more like the flu.”

Estimates of SARS-CoV-2 Seroprevalence and Incidence of Primary SARS-CoV-2 Infections Among Blood Donors, by COVID-19 Vaccination Status — United States, April 2021–September 2022 “By the third quarter of 2022, an estimated 96.4% of persons aged ≥16 years in a longitudinal blood donor cohort had SARS-CoV-2 antibodies from previous infection or vaccination, including 22.6% from infection alone and 26.1% from vaccination alone; 47.7% had hybrid immunity. Hybrid immunity prevalence was lowest among adults aged ≥65 years.”

About health insurance/insurers

 UnitedHealth offers over $3 bln for home health firm Amedisys “UnitedHealth Group on Monday made a surprise $3.26 billion all-cash offer to acquire Amedisys Inc, pitting itself against another healthcare company set to buy the home health and hospice care firm…
UnitedHealth, through its Optum unit, offered to pay $100 per share in cash, just a month after Amedisys agreed to be bought by Option Care Health Inc for $97.38 per share in an all-stock deal.”

Google, Humana adding secure insurance cards to digital wallet “Google is adding health insurance cards to its digital wallet to make it easier for patients to furnish that information to healthcare providers.
The tech giant is working with Humana to develop a digital version of the payer's cards to save to Google Wallet.”

Health Insurance For People Younger Than Age 65: Expiration Of Temporary Policies Projected To Reshuffle Coverage, 2023–33 “The Congressional Budget Office estimates that in 2023, 248 million people in the US who are younger than age sixty-five have health insurance coverage (mostly through employment-based plans), and twenty-three million people, or 8.3 percent of that age group, are uninsured—with significant variations in coverage by income and, to a lesser extent, by race and ethnicity. The unprecedented low uninsurance rate is largely attributable to temporary policies that kept beneficiaries enrolled in Medicaid and enhanced the subsidies available through the health insurance Marketplaces during the COVID-19 pandemic. As the continuous eligibility provisions unwind in 2023 and 2024, an estimated 9.3 million people in that age group will transition to other forms of coverage, and 6.2 million will become uninsured. If the enhanced subsidies expire after 2025, 4.9 million fewer people are estimated to enroll in Marketplace coverage, instead enrolling in unsubsidized nongroup or employment-based coverage or becoming uninsured. By 2033 the uninsurance rate is projected to be 10.1 percent, which is still below the 2019 rate of about 12 percent.”

About pharma

 Women more likely than men to skip or delay medications due to cost, CDC report finds “The finding came from the CDC’s National Health Interview Survey, an annual survey in which tens of thousands of people in the U.S. are asked questions about their health-related experiences.
It found that in 2021, 9.2 million adults ages 18 to 64 — about 1 in 10 — reported skipping, delaying or using less medication than prescribed over the past year to save money. Women led men when it came to this nonadherence: 9.1% versus 7%.”
The article explores possible reasons for this finding.

Inflationary Rebates For Generic Drugs Sold Through Medicaid Saved Billions During 2017–20 The authors “ found that nearly half of generic drugs were subject to inflationary rebates during the period 2017–20, offsetting 2–12 percent of the $53.6 billion in generic drug spending during that time. Rebates were larger among non–orally administered drugs and those with the highest prices. Generic inflationary rebates offset substantial Medicaid spending during that period, suggesting that many generic prices increased above inflation despite the new policy. This might change now that inflationary rebates have been expanded to Medicare under the Inflation Reduction Act of 2022, although additional policies that ensure competitive markets would better protect all US patients from rising generic drug prices.”

About healthcare IT

 Pharma giant Bayer moves deeper into digital health with new business unit “Pharma giant Bayer is launching a precision health unit as it ramps up its investment in consumer-facing digital health tools.
The company will prioritize developing products that enable people to take greater control of their own personal health through digital solutions that facilitate more informed choices based on personal insights and novel delivery mechanisms, the company said in a press release.”

The Digital Front Door 2023: The State of Patient Access Most survey respondents – patients and providers – indicate that the healthcare access experience is the same or worse than it was over the past 12 to 24 months. Despite the relatively positive progression of responses from 2020 to 2022, the level of expectation appears to have escalated in the post- pandemic environment. Calling the patient access experience ‘the same’ following unprecedented pandemic chaos is a sign that more work is needed and ‘worse’ is troubling since much effort and budget have been spent to make improvements. Interestingly, more providers than patients view access as being worse (47% compared to 21%) and better (27% compared to 17%), which may indicate the business objectives tied to improving patient access – such as accurate information intake, fewer cancellations, more patient volume handled more efficiently, better up-front collection rates – are either not yet meeting expectations or are starting to show promise. Conversely, many more patients (62%) felt access to healthcare is ‘about the same’ than did providers (25%). Providers leaned more into’“worse’ or ‘better,”’underscoring that not much has stayed the same for healthcare workers over the past few years.”

About health technology

More than 400 Grail patients incorrectly told they may have cancer “According to an internal company document seen by the Financial Times, 408 patients were incorrectly told they had a signal in their blood suggesting they could have cancer. Grail said the letters were sent “in error” by its telemedicine provider PWNHealth and that its staff had moved swiftly to contact affected customers to reassure them their test results were wrong.”

Today's News and Commentary

About hospitals and healthcare systems

Tenet Healthcare agrees to $30M whistleblower settlement over alleged kickbacks at Detroit Medical Center The government alleged that the False Claims Act violations occurred between 2014 and 2017 and involved two DMC hospitals—Sinai Grace Hospital and Harper University Hospital—providing the services of mid-level, employed practitioners to 13 physicians “at no cost or below fair market value in violation of the Anti-Kickback Statute,” DOJ wrote in a press release.
These physicians were allegedly selected due to the large number of patients they referred to the hospitals and for the purpose of increasing Medicare referrals to DMC’s facilities, DOJ said.”

About pharma

Coherus to price Humira biosimilar at 85% discount to AbbVie's product  “Coherus BioSciences disclosed Thursday that it will price Yusimry, its biosimilar version of AbbVie's Humira (adalimumab), at an 85% discount when it launches in the US next month. According to the company, Yusimry will carry a list price of $995 per carton of two autoinjectors, versus $6922 for the originator product.”
Note: Eight Humira biosimilars are expected to be on the market by the end of the year.

About health technology

 Startups’ Patch Technologies Could Extend Reach of Vaccines “In several countries the effort to eradicate measles runs into the logistical obstacle of insufficient cold storage for vaccines.   
Patches from startups including Micron Biomedical and Vaxxas could overcome this difficulty and extend the reach of vaccines in nations where measles outbreaks occur because of relatively low vaccination rates. Measles vaccine doses are sensitive to heat and must be kept cold.
That isn’t a concern in the U.S., but is an obstacle to vaccinations in remote areas of sub-Saharan Africa and other locations where access to electricity and refrigeration is limited, researchers say.
Atlanta-based Micron says its patch significantly reduces or eliminates the need for cold storage of drugs and vaccines."

Labcorp launches liquid biopsy to detect cancer-related biomarkers “A new blood test from Labcorp could potentially help cancer patients begin the most efficient treatments as early as possible.
The Plasma Focus liquid biopsy requires only a standard blood draw to run. It looks through the sample for bits of cell-free DNA (cfDNA) that are released by tumor cells into the bloodstream and that may offer insights into the cancer treatments that’ll work most effectively for a specific patient…
The newly launched test analyzes the cfDNA in a blood sample to build a genomic profile of a patient’s tumor. It looks specifically for mutations in 33 genes—comprising biomarkers that indicate variations in non-small cell lung, colorectal, breast, esophageal, gastroesophageal junction and gastric cancers and melanoma.”
Note: The article did not provide cost information on the test.

Today's News and Commentary

About health insurance/insurers

Higher patient volume, insurance enrollment helps hike Highmark Health's revenue to $6.7B in Q1 “Despite having to weather inflation, staffing shortages and interruptions in its supply chain, Highmark Health’s revenue grew 4.6% in the first quarter of 2023 to $6.7 billion, mostly because of a 2.5% increase in health insurance enrollment and higher patient volume at its Allegheny Health Network arm.
The Pittsburgh-based payer-provider organization also saw an operating gain of $136 million and net income of $227 million year over year, according to its first-quarter earnings report. The company maintained $11 billion in cash and investments and net assets of more than $9 billion.”

About hospitals and healthcare systems

 6 health systems making gains, 6 reporting operating losses FYI

Missouri nonprofit health systems BJC HealthCare, Saint Luke's targeting $10B merger “BJC HealthCare of St. Louis and Saint Luke’s Health System of Kansas City are exploring a merger that would yield a 28-hospital, $10 billion, integrated, academic health system, the nonprofits announced Wednesday.
The two have signed a nonbinding letter of intent and ‘are working toward reaching a definitive agreement in the coming months’ with a targeted close before the end of the year, they said. The cross-market deal would be subject to regulatory review and other customary closing conditions.”

Where CVS, Walmart, Kaiser, Target rank in market share for retail clinics FYI
For a comprehensive analysis of this sector, see: Retailers in healthcare: A catalyst for provider evolution

About pharma

Medicare to expand coverage for a new class of costly Alzheimer’s drugs “Medicare officials announced plans Thursday to broadly cover a new class of Alzheimer’s drugs following an intense lobbying campaign by patient advocates and drugmakers pressing for access to the first medications shown to slow cognitive decline from the disease…
The new policy marks a sharp change from an earlier one, which required patients to be in clinical trials for coverage. The plan would provide coverage to patients whose doctors take part in registries that provide information on how the drugs work.”

 US FDA approves Pfizer's RSV vaccine “The U.S. Food and Drug Administration on Wednesday approved Pfizer Inc's respiratory syncytial virus (RSV) vaccine for older adults, making it the second shot against the common respiratory disease that can be fatal for seniors.
The approval comes less than a month after the FDA approved a similar shot by rival GSK Plc. Pfizer's vaccine was approved for people aged 60 and older, the company said, the same age group as GSK's shot.”

U.S. Supreme Court gives boost to whistleblowers in drug pricing case “The justices in a 9-0 decision threw out a lower court's ruling that said the pharmacies could not be held responsible for fraud in whistleblower cases pursued against Safeway Inc, owned by Albertsons Companies Inc, and SuperValu Inc, part of United Natural Foods Inc.
At issue was whether companies can avoid liability for fraud by showing that an ‘objectively reasonable’ reading of the law supported their conduct - regardless of whether they truly believed that interpretation at the time of their alleged wrongdoing.”

Distributional Cost-Effectiveness of Equity-Enhancing Gene Therapy in Sickle Cell Disease in the United States “Gene therapy is a potential cure for sickle cell disease (SCD). Conventional cost-effectiveness analysis (CEA) does not capture the effects of treatments on disparities in SCD, but distributional CEA (DCEA) uses equity weights to incorporate these considerations…
To compare gene therapy versus standard of care (SOC) in patients with SCD by using conventional CEA and DCEA.cost-effectiveness analysis…
Gene therapy versus SOC for females yielded 25.5 versus 15.7 (males: 24.4 vs. 15.5) discounted lifetime QALYs at costs of $2.8 million and $1.0 million (males: $2.8 million and $1.2 million), respectively, with an ICER of $176 000 per QALY (full SCD population)…
Gene therapy is cost-ineffective per conventional CEA standards but can be an equitable therapeutic strategy for persons living with SCD in the United States per DCEA standards.”

About the public’s health

Biden plans to pick physician Mandy Cohen to lead CDC “President Biden plans to select former North Carolina health secretary Mandy Cohen to lead the Centers for Disease Control and Prevention, according to three people with direct knowledge of the pending announcement.”

US births in 2022 didn’t return to pre-pandemic levels “U.S. births were flat last year, as the nation saw fewer babies born than it did before the pandemic, the Centers for Disease Control and Prevention reported Thursday.
Births to moms 35 and older continued to rise, with the highest rates in that age group since the 1960s. But those gains were offset by record-low birth rates to moms in their teens and early 20s, the CDC found. Its report is based on a review of more than 99% of birth certificates issued last year.
A little under 3.7 million babies were born in the U.S. last year, about 3,000 fewer than the year before.”

AMA and others launch collective call for health equity in Rise to Health “On Tuesday, the American Medical Association, the Institute for Healthcare Improvement (IHI) and Race Forward officially launched Rise to Health, a call to action for providers, payers, pharma and professional societies to make health equity a priority…
Rise to Health: A National Coalition for Equity in Health Care has been in the works for about two years. Its ten founders include the AMA, American Hospital Association and AHIP.”

Cash-transfer programmes reduce mortality in low- and middle-income countries “Cash-transfer programmes have emerged as central components of poverty-reduction strategies in many countries, and became even more common during the COVID-19 pandemic. An analysis of 37 low- and middle-income countries finds that these programmes led to marked reductions in population-level mortality in adult women and young children.”

About healthcare IT

 Walmart investors vote down bid to study consumers' data privacy and reproductive rights “Walmart investors voted Wednesday to reject a push from some company shareholders to conduct an independent study on consumers' data privacy and reproductive rights.
The proposal requested that the company investigate known and potential risks associated with filling information requests from law enforcement and other agencies that could criminalize patients seeking abortions. It received 5.2% of shares that were voted, according to a release from the company, a required a majority of total voting shares to be affirmative to pass.”

About healthcare personnel

 Healthcare sector job cuts up 81% from 1st 5 months of 2022 “Healthcare/products, which includes hospitals and medical products manufacturers, announced the fourth-most job cuts among 30 industries and sectors measured in the first five months of 2023, according to one new analysis.
The finding comes from a June 1 report from Challenger, Gray & Christmas, an executive coaching firm that examines job cuts by U.S.-based employers.
Healthcare/products announced 33,085 job cuts in the first five months of 2023, up 81 percent from the 18,301 announced in the sector in the same period of 2022. In May alone, healthcare/products announced 3,951 job cuts, compared to 6,184 in the previous month.”

Today's News and Commentary

About health insurance/insurers

 Estimated Costs of Intervening in Health-Related Social Needs Detected in Primary Care Findings  In this decision analytical model with a simulated sample based on data of 19 225 noninstitutionalized children and adults of all ages seen in primary care practices, the cost of providing evidence-based interventions for social needs averaged $60 per member per month.
Meaning  The findings of this study suggest that substantial resources would be needed to implement a comprehensive approach to addressing social needs that falls largely outside of existing federal financing mechanisms.”
Comment: This article draws a distinction between social insurance and health insurance, despite the obvious link between health and social determinants of disease. $60 per member per month would be an expensive addition to a health insurance policy and would result in fewer people being insured. We need to find a political and financial solution to to funding these needs.
For a thoughtful editorial, see: Addressing Health-Related Social Needs—Costs and Optimism

About hospitals and healthcare systems

MAY 2023 National Hospital Flash Report
“Key Takeaways

  1. Hospitals broke even in April.

    The median operating margin for hospitals was 0% in April, leaving most hospitals with little to no financial wiggle room.

  2. Volumes dropped while lengths of stay increased.

    Hospital volumes dropped across the board—including inpatient and outpatient. Emergency department volumes were the least affected.

  3. Effects of Medicaid disenrollment could be materializing.

    Hospitals experienced increases in bad debt and charity care in April. Combined with anemic patient volumes, experts note this data could illustrate the effects of the start of widespread disenrollment from Medicaid following the end of the COVID-19 public health emergency.

  4. Inflation continued to throttle hospital finances.

    Labor costs jumped in April and the costs of goods and services continued to be well above pre-pandemic levels. Though expenses generally fell in April, revenues declined at a faster rate.”


Advocate Health reports 0.1% operating margin, $579M net gain for its first post-merger quarter “Advocate Health, the newly formed marriage of major nonprofits Advocate Aurora Health and Atrium Health, reported a $10.4 million operating income (0.1% operating margin) and $578.7 million net gain in its first-ever first-quarter earnings report released Tuesday.
The 67-hospital entity tallied more than $7.54 billion in total revenue during the three months ended March 1 thanks to year-over-year increases across each of its major divisions—Advocate Aurora Health, Atrium Health’s Charlotte-Mecklenburg Hospital Authority and Atrium Health Wake Forest Baptist.”

About pharma

 FDA proposes revamping medication guides that come with prescriptions “The US Food and Drug Administration proposed Tuesday to add to what you get with your prescription drugs.
The proposed rule would require the prescriptions you get to come with a new kind of single-page medication guide with an easy-to-use set of directions and easy-to-understand safety information, a goal the FDA has been working toward for years.”

This panel will decide whose medicine to make more affordable. Its choice will be tricky An excellent review of state-initiated pharma cost controls. Some of the questions that must be answered are: “Do they tackle drugs with extremely high costs taken by only a handful of patients, or drugs with merely very high costs taken by a larger group? Should they consider only out-of-pocket costs paid by consumers…, or the total cost of the drug to the health system? Will they weigh only drug prices, or will they try to right social wrongs with their choices?”

About healthcare IT

 AI Improves Stroke Recognition in Emergency Calls “The model was trained using data on 1.5 million calls to the emergency services between 2015 and 2020, of which 7370 turned out to be actual stroke cases. It was then tested on 2021 data on 344,000 calls of which 750 were stroke cases.
Results showed that the AI model correctly identified 63% of patients who were having a stroke, a better result than the human emergency call dispatchers who recognized just 52.7% of stroke cases.”

Today's News and Commentary

What's in — and out — of the debt ceiling deal A really good summary of the healthcare terms of the proposed budget compromise. Highlights include the exclusion of Medicaid work requirements and a claw back of billions in covid-19 relief funds.

About health insurance/insurers

The Value of Employer-Provided Coverage in 2023 “Most consumers (63%) are satisfied with their current employer-provided coverage, and the vast majority (68%) prefer to get their coverage through their employer rather than through the federal or state government. This satisfaction is driven by the comprehensive coverage, affordability, and choice of providers their plans provide. In addition, a majority (59%) feel the quality of their current health insurance plan is high.
During this time of high inflation and rising cost of living, costs remain a top concern for consumers. Encouragingly, a majority of those with employer-provided coverage (53%) report that what they currently pay for coverage overall is reasonable.”
Note: This independent study was commissioned by AHIP.

Milliman Medical Index: Healthcare costs exceed $31,000 for hypothetical American family of four “In 2023, healthcare costs for our hypothetical family of four reached $31,065. Costs for the average person reached $7,221. While these are averages, the MMI provides greater specificity thanks to an interactive tool that allows people to calculate costs for themselves or their own family. To use the interactive tool, go to http://us.milliman.com/MMIfamilies/.”
Note: The figures are averages for an employer-sponsored PPO.

The Shadowy Financial Empire Built Around Liberty HealthShare Is Showing Signs of Strain A great investigative piece by ProPublica that points out the flimsy coverage of ministry-based insurance plans.

Payers ranked by Medicaid membership | Q1 2023 FYI

Healthcare billing fraud: 10 recent cases FYI. Amazing what people attempt to do.

About hospitals and healthcare systems

Ascension posts $1.4B Q1 operating loss  “A decline in COVID-19 funding and sustained expenses issues helped lead St. Louis-based Ascension to a $1.8 billion operating loss in the nine months ending March 31.
The nine-month loss was on revenue of $21.3 billion. In the quarter ending March 31, the 140-hospital system reported an operating loss of $1.4 billion on $6.9 billion in revenue.
Such losses compared with $640 million and $671 million deficits in the nine-month and three-month periods, respectively, ending March 31, 2022.”

Trinity Health reports $283.5M operating loss “Livonia, Mich.-based Trinity Health, one of the largest nonprofit health systems in the country, reported an operating loss of $283.5 million for the first nine months of its fiscal year up to March 31.
The loss, which included a reduction of $137.2 million from pandemic-related provider relief funds compared with the same period in 2022, also compared with an operating gain of $139.7 million in 2022.”

About pharma

Sacklers win appeal that shields them from opioid lawsuits, clearing way for bankruptcy settlement “Afederal appeals court ruled Tuesday Purdue Pharma can shield its owners — members of the wealthy Sackler family — from thousands of lawsuits over the role the company played in the opioid crisis in exchange for a contribution of up to $6 billion to a proposed bankruptcy settlement.”

About the public’s health

With population of aging Americans growing, U.S. median age jumps to nearly 39 “The share of residents 65 or older grew by more than a third from 2010 to 2020 and at the fastest rate of any decade in 130 years, while the share of children declined, according to new figures from the most recent census.
The declining percentage of children under age 5 was particularly noteworthy in the figures from the 2020 head count released Thursday. Combined, the trends mean the median age in the U.S. jumped from 37.2 to 38.8 over the decade.
America’s two largest age groups propelled the changes: more baby boomers turning 65 or older and millennials who became adults or pushed further into their 20s and early 30s. Also, fewer children were born between 2010 and 2020, according to numbers from the once-a-decade head count of every U.S. resident.”

About healthcare IT

New collaboration opens CPT content for developers Under a new collaboration between Health Level Seven® International (HL7®) and the American Medical Association (AMA), technology developers using HL7 data interoperability standards and guides will have increased accessibility to AMA-published medical codes and descriptors. The collaboration will work to fully integrate HL7 Fast Healthcare Interoperability Resources (FHIR®) with the AMA’s Current Procedure Terminology (CPT®) code set to advance the organizations’ mutual goal of promoting the efficient exchange of interoperable health information.”

 Top 10 remote patient monitoring platforms, per KLAS FYI

About healthcare personnel

Comparison of Hospital Outcomes for Patients Treated by Allopathic Versus Osteopathic Hospitalists “The results can rule out important differences in quality and costs of care between allopathic versus osteopathic physicians for patient mortality (adjusted mortality, 9.4% for allopathic physicians vs. 9.5% [reference] for osteopathic hospitalists; average marginal effect [AME], −0.1 percentage point [95% CI, −0.4 to 0.1 percentage point]; P = 0.36), readmission (15.7% vs. 15.6%; AME, 0.1 percentage point [CI, −0.4 to 0.3 percentage point; P = 0.72), LOS (4.5 vs. 4.5 days; adjusted difference, −0.001 day [CI, −0.04 to 0.04 day]; P = 0.96), and health care spending ($1004 vs. $1003; adjusted difference, $1 [CI, −$8 to $10]; P = 0.85).
Limitation: Data were limited to elderly Medicare patients hospitalized with medical conditions.
Conclusion: The quality and costs of care were similar between allopathic and osteopathic hospitalists when they cared for elderly patients and worked as the principal physician in a team of health care professionals that often included other allopathic and osteopathic physicians.”

About health technology

 Groundbreaking Israeli cancer treatment has 90% success rate “The treatment [for multiple myeloma] is based on genetic engineering technology, which is an effective and groundbreaking solution for patients whose life expectancy was only two years until a few years ago. They have used a genetic engineering technology called CAR-T, or Chimeric Antigen Receptor T-Cell Therapy, which boosts the patient’s own immune system to destroy the cancer. More than 90% of the 74 patients treated at Hadassah [Medical Center in Jerusalem] went into complete remission, the oncologists said.”

Today's News and Commentary

About Covid-19

FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults Thursday, “the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.
Paxlovid manufactured and packaged under the emergency use authorization (EUA) and distributed by the U.S. Department of Health and Human Services will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by today’s approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.”

BioNTech is proceeding with COVID-shot in line with WHO guidance “Germany's BioNTech said it was on track to introduce a COVID-19 shot by the early fall in the northern hemisphere that is adapted to currently dominant virus variants in line with recommendations by the World Health Organization.”

Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection Question  What symptoms are differentially present in SARS-CoV-2–infected individuals 6 months or more after infection compared with uninfected individuals, and what symptom-based criteria can be used to identify postacute sequelae of SARS-CoV-2 infection (PASC) cases?…
Adjusted odds ratios were 1.5 or greater (infected vs uninfected participants) for 37 symptoms. Symptoms contributing to PASC score included postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements. Among 2231 participants first infected on or after December 1, 2021, and enrolled within 30 days of infection, 224 (10% [95% CI, 8.8%-11%]) were PASC positive at 6 months.”
Comment: Clearly, these non-specific symptoms do not constitute solid diagnostic criteria. As the authors point out: “iterative refinement that further incorporates other clinical features is needed to support actionable definitions of PASC.”

About health insurance/insurers

Average hospital payer mix in every state FYI. While you might guess Florida, Maryland has the highest Medicare mix (29.6 percent), closely followed by Delaware (29.5 percent).

Than Age 65: Expiration Of Temporary Policies Projected To Reshuffle Coverage, 2023–33 “The Congressional Budget Office estimates that in 2023, 248 million people in the US who are younger than age sixty-five have health insurance coverage (mostly through employment-based plans), and twenty-three million people, or 8.3 percent of that age group, are uninsured—with significant variations in coverage by income and, to a lesser extent, by race and ethnicity. The unprecedented low uninsurance rate is largely attributable to temporary policies that kept beneficiaries enrolled in Medicaid and enhanced the subsidies available through the health insurance Marketplaces during the COVID-19 pandemic. As the continuous eligibility provisions unwind in 2023 and 2024, an estimated 9.3 million people in that age group will transition to other forms of coverage, and 6.2 million will become uninsured. If the enhanced subsidies expire after 2025, 4.9 million fewer people are estimated to enroll in Marketplace coverage, instead enrolling in unsubsidized nongroup or employment-based coverage or becoming uninsured. By 2033 the uninsurance rate is projected to be 10.1 percent, which is still below the 2019 rate of about 12 percent.”

Home Health Value-Based Purchasing Model Lowered Medicare Spending “The Home Health Value-Based Purchasing (HHVBP) Model reduced Medicare spending by $1.38 billion and improved care quality during its first six years, according to a report from CMS.
The CMS Innovation Center implemented the original HHVBP Model in nine states from January 2016 to December 2021: Arizona, Florida, Iowa, Massachusetts, Maryland, Nebraska, North Carolina, Tennessee, and Washington.
The model aimed to improve the quality of home healthcare services for Medicare beneficiaries by providing financial incentives to home health agencies for quality improvements. Home health agencies received performance scores for individual measures of quality of care that were combined into a total performance score to determine their payment adjustment.”

Comparison of Out-of-Pocket Spending on Ultra-Expensive Drugs in Medicare Part D vs Commercial Insurance “Findings  This cohort study including 37 324 Part D beneficiaries and 24 159 commercially insured individuals showed that Medicare Part D beneficiaries without low-income subsidies spent 2.5 times more out of pocket on ultra-expensive drugs and were subject to greater variation in this spending compared with commercially insured patients aged 45 to 64 years.
Meaning  Recent legislation establishing a $2000 out-of-pocket cap in Part D has the potential to lower out-of-pocket costs for more than 125 000 Part D beneficiaries who use ultra-expensive drugs and are ineligible for low-income subsidies, thus ameliorating increases in out-of-pocket spending when transitioning from commercial insurance to Part D.”

CVS could lose up to $1B next year from MA star ratings drop Dive Brief:

  • CVS expects its 2024 operating income to drop by $800 million to $1 billion next year due to lost bonus payments from lower plan star ratings in the Medicare Advantage program.

  • Just 21% of CVS’ MA members are currently in plans with a star rating of at least four, down from 87% at the end of 2021, the payer disclosed in a filing with the Securities and Exchange Commission on Thursday. Plans with a rating of four or above are eligible for bonus payments.

  • CVS’ score for its largest MA plan, Aetna National PPO, dropped from 4.5 to 3.5 stars. That was the main driver of the overall decrease in MA members in highly rated plans, CVS said. As a result, the plan — one of the largest in the U.S., with more than 1.9 million members — is no longer eligible for quality bonus payments in 2024.”

About hospitals and healthcare systems

Kaiser, Cleveland Clinic and more: 6 nonprofit systems back in the black “March was the first time in 15 months that revenue growth outpaced expense increases, according to a report from Syntellis. The median hospital year-to-date operating margin in March was 0.4 percent, up from -1.1 percent in February.”

About pharma

 FDA pushes back Sarepta DMD gene therapy decision Sarepta Therapeutics announced that the FDA has delayed a decision on its gene therapy application for ambulant patients with Duchenne muscular dystrophy (DMD)…The agency had been expected to render a decision on SRP-9001 (delandistrogene moxeparvovec) by May 29, but that has now been pushed back to June 22 to allow ‘modest additional time’ to complete its review, including final label negotiations and post-marketing commitment discussions, the drugmaker said.
The deferral comes on the heels of an FDA advisory panel that narrowly backed an accelerated approval for the AAV vector-based gene therapy with a vote of 8 to 6 in favour.”

About the public’s health

Multivitamin supplementation improves memory in older adults: A randomized clinical trial “…we estimate that the effect of the multivitamin intervention improved memory performance above placebo by the equivalent of 3.1 years of age-related memory change.”
For your comparison, the authors used Centrum Silver vitamins.

The top 5 medical services Americans are skipping “Financial uncertainty and the high cost of medical expenses have caused many people to forgo medical treatment, a Federal Reserve report released in May found
In 2022, 28 percent of adults went without some form of medical care because they could not afford it. The following were the top five medical services Americans did not undergo due to cost (Note: Survey participants could vote for more than one option):

1. Dental care: 21 percent

2. Physician or specialist visit: 16 percent

3. Prescription medication: 10 percent

3. Follow-up care: 10 percent

3. Mental healthcare: 10 percent”

About healthcare IT

Logging on for health: More older adults use patient portals, but access and attitudes vary widely “Overall, 78% of people aged 50 to 80 have used at least one patient portal, up from 51% in a poll taken five years ago, according to findings from the University of Michigan National Poll on Healthy Aging. Of those with portal access, 55% had used it in the past month, and 49% have accounts on more than one portal…
Older adults with annual household incomes below $60,000, and those who are Black or Hispanic, have lower rates of portal use, and were less likely to say they’re comfortable using a portal, than respondents who are higher-income or non-Hispanic white. 
There were also differences among older adults who don’t use portals, or haven’t used one in three or more years. Those who say they’re in fair or poor health physically or mentally were much more likely to say they’re not confident about their ability to log in and navigate a portal than those with better physical or mental health.”

Diverse patients’ attitudes towards Artificial Intelligence (AI) in diagnosis “Our main outcome measure was selection of AI clinic or human physician specialist clinic (binary, “AI uptake”). We found that with weighting representative to the U.S. population, respondents were almost evenly split (52.9% chose human doctor and 47.1% chose AI clinic). In unweighted experimental contrasts of respondents who met pre-registered criteria for engagement, a PCP’s explanation that AI has proven superior accuracy increased uptake (OR = 1.48, CI 1.24–1.77, p < .001), as did a PCP’s nudge towards AI as the established choice (OR = 1.25, CI: 1.05–1.50, p = .013), as did reassurance that the AI clinic had trained counselors to listen to the patient’s unique perspectives (OR = 1.27, CI: 1.07–1.52, p = .008). Disease severity (leukemia versus sleep apnea) and other manipulations did not affect AI uptake significantly. Compared to White respondents, Black respondents selected AI less often (OR = .73, CI: .55-.96, p = .023) and Native Americans selected it more often (OR: 1.37, CI: 1.01–1.87, p = .041). Older respondents were less likely to choose AI (OR: .99, CI: .987-.999, p = .03), as were those who identified as politically conservative (OR: .65, CI: .52-.81, p < .001) or viewed religion as important (OR: .64, CI: .52-.77, p < .001). For each unit increase in education, the odds are 1.10 greater for selecting an AI provider (OR: 1.10, CI: 1.03–1.18, p = .004). While many patients appear resistant to the use of AI, accuracy information, nudges and a listening patient experience may help increase acceptance. To ensure that the benefits of AI are secured in clinical practice, future research on best methods of physician incorporation and patient decision making is required.”

Startup Florence acquires Zipnosis from Bright Health to build out telehealth services “On the heels of its official launch last month, health tech startup Florence picked up Zipnosis from Bright Health to expand its virtual care capabilities.
Bright Health, which is looking to shed business lines as it tries to stave off bankruptcy, bought the white-labeled virtual care solution just two years ago. Bright Health revealed March 1 that it had overdrawn its credit and would need to secure $300 million by the end of April to stay afloat.”

About healthcare personnel

Flash Report: Health System Workforce Market & Solutions A great quick look at the state if this issue. Among the findings: Health system labor expenses increased 20% in the twelve months prior to March 2023 compared to pre-pandemic levels, largely driven by growth of contract labor. Contract hours relative to paid hours were up 91% in March 2023 from March 2020.
Nursing shortages are at the forefront of workforce difficulties.The average professional tenure of nurses dropped from 3.6 years prior to the pandemic to just 2.8 years in 2023.”

A REUTERS SPECIAL REPORT How doctors buy their way out of trouble “Over the last decade alone, at least 540 doctors and healthcare practitioners collectively paid the government hundreds of millions of dollars to negotiate their way out of trouble via civil settlements, then continued to practice medicine without restrictions on their licenses despite allegations that included fraud and patient harm, a Reuters investigation found. That figure is the result of the first-ever comprehensive analysis of federal civil settlements and state disciplinary actions.”

About health technology

Medtronic acquires insulin patch pump maker EOFlow for $738M amid new MiniMed rollout “Medtronic is set to acquire EOFlow, the South Korea-based maker of an insulin patch pump. In its announcement of the deal Thursday, Medtronic suggested that integrating the tubeless device with its own continuous glucose monitors and meal-detection algorithm—both of which can also be used alongside the MiniMed pumps—could create a new closed-loop system for largely hands-off diabetes management.”

Today's News and Commentary

About health insurance/insurers

 Payers ranked by commercial membership | Q1 2023 Elevance (formerly Anthem) is #1.

About hospitals and healthcare systems

 1,129 hospitals reporting losses on patient services, state-by-state “Rural hospitals across the U.S. are taking losses on patient services, meaning insurers aren't paying enough to cover the cost of care delivery, according to a report from the Center for Healthcare Quality & Payment Reform.
Losses on patient services have forced some hospitals to close service lines and reduce access to care in already underserved communities. There are more than 600 hospitals at risk of closure across the U.S. as well due to financial constraints and inflation.”

About pharma

 Top PBMs by 2022 market share FYI. CVS Caremark is at the top with 33% market share.

 New overdose antidote approved, but concerns raised about cost, side effects “The Food and Drug Administration on Monday approved a nasal-spray medication touted as another option to reverse overdoses caused by synthetic opioids, including fentanyl, the drug killing tens of thousands of Americans each year.
Drugmaker Indivior describes Opvee, a spray version of the drug nalmefene, as a potent medication that will save lives by acting quickly to reverse an overdose while potentially protecting against more overdoses for hours. But some public health experts, physicians and community groups are raising concerns that Opvee may burden taxpayers despite other proven, cheaper medications such a naloxone while causing agonizing, long-lasting withdrawal symptoms for some drug users after they are revived.”

Purdue Pharma to Sell Consumer Business for $397 Million “Purdue Pharma on Tuesday received a US judge's permission to offload its consumer health business for $397 million to a subsidiary of Arcadia Consumer Healthcare, reported U.S. News & World Report.
US Bankruptcy Judge Sean Lane approved Purdue's sale of Avrio Health, allowing Purdue to begin liquidating its assets while it awaits a final ruling on a $10-billion settlement that would devote the company's remaining resources to combating the US opioid epidemic.”

U.S. proposes new rule to increase transparency of prescription drug costs for Medicaid “The U.S. health department on Tuesday proposed a rule aimed at cutting costs of prescription drugs for the Medicaid healthcare program for the poor by increasing transparency around how much those drugs actually cost.
The proposed rule would also hold drugmakers accountable for providing the correct discounts to the state-based Medicaid plans for drugs.
The Centers for Medicare and Medicaid Services (CMS) proposed that contracts between states, health insurers and third-party contractors such as pharmacy benefit managers show how much those PBMs are paying for the drugs to avoid discrepancies in what they charge Medicaid and what they reimburse pharmacies.”

Walgreens asks federal court to toss 'staggering' $642M arbitration award to Humana Read the entire article for the complete story. It will be in the news for a long time.

Walgreens Nears Settlement In Theranos MDL “Walgreens has reached a settlement in principle with a class of customers who submitted Theranos blood tests in a years-long case alleging the pharmacy chain should have known the tests were faulty when it helped market them.”

About the public’s health

 What is Driving Widening Racial Disparities in Life Expectancy? “This analysis examines trends in life expectancy and leading causes of death by race and ethnicity and discusses the factors that contribute to racial disparities in life expectancy. In sum, it finds:

  • There was a sharp drop-off in life expectancy between 2019 and 2021, with particularly large declines among some groups. American Indian and Alaska Native (AIAN) people experienced the largest decline in life expectancy of 6.6 years during this time, followed by Hispanic and Black people (4.2 and 4.0 years, respectively).

  • Reflecting these declines, provisional data for 2021 show that life expectancy was lowest for AIAN people at 65.2 years, followed by Black people, whose expectancy was 70.8 years, compared with 76.4 years for White people and 77.7 years for Hispanic people. It was highest for Asian people at 83.5 years. Data were not reported for Native Hawaiian and Other Pacific Islander (NHOPI) people.

  • These declines were largely due to COVID-19 deaths and reflect the disproportionate burden of excess deaths, including premature excess deaths (before age 75), among people of color during the pandemic. Although COVID-19 mortality was a primary contributor to the recent decrease in life expectancy across groups, leading causes of death vary by race and ethnicity.”

Surgeon General issues advisory that social media is contributing to youth mental health crisis “Murthy specifically pointed to the possibility of a link between time spent on social media and depression and anxiety.
He cited one 2019 study that found adolescents between the ages of 12 and 15 who spent more than three hours on social media daily had double the risk of developing symptoms of depression and anxiety.
Teenagers on average spend 3 1/2 hours on social media every day, according to data cited in the advisory.

About healthcare IT

Mayo Clinic, Johns Hopkins and 20 others pledge to join TEFCA, prioritize interoperability “Epic announced the first cohort of health systems pledging to join the national health information-sharing network dubbed the Trusted Exchange Framework and the Common Agreement (TEFCA).
Epic is a member of the inaugural group of six prospective Qualified Health Information Networks (QHINs) that were recognized by the Department of Health and Human Services (HHS) earlier this year. Today, Epic announced that 20 health systems along with health tech company KeyCare and health information exchange OCHIN will be joining TEFCA with the goal of increasing interoperability in healthcare.”
Note: See the Information Technology chapter in the Book for more information about TEFCA. 

State Telehealth Laws and Reimbursement Policies “This chart provides a quick reference summary of each state’s telehealth policy on Medicaid reimbursement, private payer reimbursement laws (both if a law exists and whether or not payment parity is required), and professional requirements around interstate compacts and consent based on information gathered between January and March 2023.”

EHR vendors ranked by hospital market share gains (and losses) No surprises on this list.

Today's News and Commentary

About health insurance/insurers

 Per a report from Stat: Why Medicare hospital spending is down
”Health policy gurus have been scratching their heads a little bit lately, because the amount of money Medicare’s trust fund has spent on hospital care in the latter half of 2022 is still well below what they expected. Now, the government’s top health care actuary has some answers.
Paul Spitalnic, the chief actuary at CMS, spoke during a webinar hosted by the American Academy of Actuaries last week and detailed three reasons for the tempered hospital spending among beneficiaries in the traditional Medicare program:  

  • The pandemic, of course. Adults who are 65 and older continue to be the most vulnerable to Covid (this demographic makes up only 13% of reported Covid cases, but 75% of Covid deaths). Medicare beneficiaries who survived Covid also are less costly.

  • People who are eligible for both Medicare and Medicaid — people who are poor, older, and often have severe disabilities or serious health conditions — increasingly are moving to Medicare Advantage.

  • Hip and knee replacements have moved to outpatient settings, which has taken pressure off Medicare’s Part A trust fund that pays for hospital care.”

An Update to the Budget Outlook: 2023 to 2033 From the CBO. Some Medicare/Medicaid highlights:
—In CBO’s current projections, federal outlays (adjusted to exclude the effects of timing shifts) rise from $6.3 trillion in 2023 to $9.8 trillion in 2033, an average annual ncrease of 4.5 percent. Outlays for Social Security
and Medicare account for over half of that $3.5 trillion increase. By 2033, outlays for Social Security, the major health care programs, and interest account for 65 percent of projected spending.
—…
two underlying factors—the aging of the population and growth in federal health care costs—put upward pressure on mandatory spending. The increase in the average age of the population causes the number of beneficiaries of Social Security and Medicare to grow faster than the overall population, and federal health care costs per beneficiary continue to rise faster than GDP per person. As a result of those two trends, outlays for Social Security and Medicare will increase from 8.2 percent of GDP in 2023 to 10.1 percent in 2033, CBO projects. The effects of those trends on fed- eral spending will persist beyond the next decade.
—The announced policy changes affecting payments to MA plans caused CBO to decrease projected spending over the 2024–2033 period by $223 billion, compared with the February baseline.

What Could New Anti-Obesity Drugs Mean for Medicare? “Lifting the current law prohibition on coverage of weight-loss drugs would come at a cost to Medicare, given the high price and expected demand. Wegovy, for example, has an annual estimated net price of $13,600. According to a recent study, if 10% of Medicare beneficiaries with obesity use Wegovy, the annual cost to Medicare could be $13.6 billion (based on a 19% obesity rate from traditional Medicare diagnoses in 2021) to $26.8 billion (based on a 41.5% obesity rate from survey data for adults ages 60 and older). Higher take-up rates would mean higher Medicare spending. For context, total annual Part D spending in 2021 was $98 billion. Of note, these estimates do not account for potential reductions in Medicare spending that could occur if weight loss drugs reduce medical spending associated with other diseases, such as heart disease.”

Denials of health-insurance claims are rising — and getting weirder Great opinion piece in The Washington Post. Here is the strangest case (in my opinion):
”An insurer’s letter was sent directly to a newborn child denying coverage for his fourth day in a neonatal intensive-care unit. ‘You are drinking from a bottle,’ the denial notification said, and ‘you are breathing on your own.’”

Crowe RCA benchmarking analysis “Crowe RCA data shows that commercial payors reimburse providers at a higher amount on a per-case basis compared with Medicare:

  • $18,156.50 is paid by commercial payors compared with $14,887.10 paid by Medicare in average net revenue per inpatient case.

  • $1,606.86 is paid by commercial payors compared with $707.30 paid by Medicare in average net revenue per outpatient case.

    It’s true that commercial payors might generate more net revenue than public payors on a per-case basis. But at what cost?

    The comprehensive Crowe RCA database tracks all aspects of payor performance, and the performance across commercial and public payors varies widely. In fact, commercial payors take the longest to pay, require providers to jump through more administrative hoops to get paid, and delay payments to providers via claim denials at a higher frequency than government payors…
    In 2022, the initial prior authorization/precertification denial rate for inpatient claims for commercial payors was 2.8%, up from 2.4% in 2021. We’re seeing more of the same again this year with the rate at more than 3% through the first three months of the year. By comparison, the denial rate for traditional Medicare was 0.2% through the first quarter of 2023.”

About pharma

 Most expensive drugs in the US in 2023 FYI

Time to Confirmatory Study Initiation After Accelerated Approval of Cancer and Noncancer Drugs in the US “The Consolidated Appropriations Act of 2023 provided that the FDA “may require” confirmatory studies to be “underway prior to approval, or within a specified time period after” accelerated approval. Since the statute permits, but does not require, the FDA to use this authority, further information regarding the timing of confirmatory study initiation and completion for cancer and noncancer products may benefit both the FDA and policy makers as they implement this legislation and consider future reforms to the accelerated approval pathway…
[This study showed that] “For 103 cancer–indication pairs and noncancer products, 20.31% (26 of 128) of confirmatory studies were not underway at the time of accelerated approval, and the median (IQR) time from approval to study initiation was 1.41 (1.10-2.04) years.”
Comment: Pharma companies are getting accelerated approvals but, in a large portion of cases, confirmatory studies were not started on time and are much delayed when started. The FDA needs to assure these studies are in progress when it grants accelerated approvals.

About the public’s health

 Global Burden, Risk Factors Analysis, and Prediction Study of Ischemic Stroke [IS], 1990–2030 “Between 1990 and 2019, the global number of IS deaths increased from 2.04 million to 3.29 million and is expected to increase further to 4.90 million by 2030. The downward trend was more pronounced in women, young people, and high social-demographic index (SDI) regions. At the same time, a study of attributable risk factors for IS found that two behavioral factors, smoking and diet in high sodium, and five metabolic factors, including high systolic blood pressure, high low-density lipoprotein cholesterol, kidney dysfunction, high fast plasma glucose, and high BMI, are major contributors to the increased disease burden of IS now and in the future.” 

About health technology

 FDA okays Krystal's Vyjuvek as first topical gene therapy for dystrophic epidermolysis bullosa You can read about the clinical indications but of significance is that this treatment is “the first redosable gene therapy…” 

Thermo Fisher's test to detect pregnancy-related complication gets FDA nod “The U.S. Food and Drug Administration (FDA) has cleared Thermo Fisher Scientific Inc's test, the first of its kind in the country, to detect women with risk of severe preeclampsia…”
Comment: Could become a standard of care, which means tremendous sales for Thermo Fisher.

Today's News and Commentary

About Covid-19

 WHO recommends new COVID shots should target only XBB variants “A World Health Organization (WHO) advisory group on Thursday recommended that this year's COVID-19 booster shots be updated to target one of the currently dominant XBB variants.
New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered.” 

About health insurance/insurers

 IRS Gives Big Boost to HSA, HDHP Limits in 2024 “Annual HSA contribution limits for 2024 are increasing in one of the biggest jumps in recent years, the IRS announced May 16: The annual limit on HSA contributions for self-only coverage will be $4,150, a 7.8 percent increase from the $3,850 limit in 2023. For family coverage, the HSA contribution limit jumps to $8,300, up 7.1 percent from $7,750 in 2023.
Participants 55 and older can contribute an extra $1,000 to their HSAs. This amount will remain unchanged.
Meanwhile, for 2024, a high-deductible health plan (HDHP) must have a deductible of at least $1,600 for self-only coverage, up from $1,500 in 2023, or $3,200 for family coverage, up from $3,000, the IRS noted. Annual out-of-pocket expense maximums (deductibles, co-payments and other amounts, but not premiums) cannot exceed $8,050 for self-only coverage in 2024, up from $7,500 in 2023, or $16,100 for family coverage, up from $15,000.
The IRS also announced it will raise the maximum amount that employers may contribute to an excepted-benefit health reimbursement arrangement (HRA) in 2024 to $2,100—up from the 2023 amount of $1,950.”

Government stats show number of uninsured declined in 2022, though experts question methodology, conclusion “The number of uninsured individuals dropped slightly in 2022, with 8.4% or 27.6 million people of all ages in the U.S. falling into that category compared to 9.2% or 30 million in 2021, according to initial estimates (PDF) from the National Center for Health Statistics (NCHS).
The data, from surveys of 27,654 adults and 7,464 children taken throughout 2022, also show that 12.2% of adults aged 18 to 64 were uninsured, while 22% in that age group had public coverage, and 67.8% had private health insurance.
Among children from birth to 17 years old, 4.2% were uninsured, 43.7% had public coverage and 54.3% had private health insurance coverage.
The report found that among non-Hispanic white adults aged 18 to 64, the percentage of uninsured people declined from 10.5% in 2019 to 7.4% in 2022. Meanwhile, people under 65 who purchased coverage on the Affordable Care Act (ACA) exchanges rose from 3.7% in 2019 to 4.3% in 2022.”

Engaging Primary Care in Value-Based Payment: New Findings from the 2022 Commonwealth Fund Survey of Primary Care Physicians “While our survey doesn’t reveal what share of a physician’s total payments are value-based, it does reveal that more PCPs are receiving FFS payment than VBP. Seventy-one percent of respondents reported that their practice was receiving any FFS payments, while fewer than half (46%) reported receiving any VBP. Similar rates of primary care practices report receiving two common types of VBP, shared savings or capitation (30% and 32%, respectively). Practices are likely receiving a combination of payments because they are paid differently by different payers.”
Comment: The first sentence is critical. Without substantial percentages of total compensation in VBPs, physician behavior will not change.

2023 EDITION High-cost claims and injectable drug trends analysis More analysis from Sun Life:
Some key insights included in this year’s report are:
—71% of all stop-loss claims came from the top 10 conditions.
—While cancer continues to be the largest driver of high-cost claims, cardiovascular disease rose one spot to the #2 claim condition in 2022, with $142.4M in reimbursements for over 2,300 members.
—11 of the top 20 high-cost injectable drugs are related to the treatment of
cancer. Rylaze, the cancer drug with the highest average cost ($808.7K), is new to the top 20 injectables drug list this year.
—Approximately one in nine employers (11%) experienced a birth-related stop- loss claim in the four-year benefit period of 2018 through 2021. Newborn/ infant care ranks at #5 in 2022, consistent with its previous ranking in the topfive last year and has one of the highest average costs at $371.8K.
—20% of employers had at least one member with over $1M in claims during
the four-year benefit period from 2018 through 2021.
—Million-dollar claims on a per million covered employees basis rose 15% in the
past year and 45% over the past four years.”

About hospitals and healthcare systems

 CMS: Hospitals Can Continue to Bill for Remote Outpatient Therapies “In a Frequently Asked Questions (FAQs) document, the Centers for Medicare and Medicaid Services (CMS) stated that hospitals could continue to bill for various outpatient therapies delivered via remote care technologies in patients' homes through the end of calendar year (CY) 2023.”

About the public’s health

Pfizer’s maternal RSV vaccine effective at preventing severe infections in newborns, FDA says, but flags potential risk of preterm birth “Pfizer’s vaccine to protect newborns from respiratory syncytial virus, or RSV, by vaccinating their moms late in pregnancy cuts the risk that infants will need to see a doctor or be admitted to the hospital with a moderate to severe infection before 6 months of age, according to a new analysis by government regulators…
 Safety data published in an agency analysis Tuesday also showed a slightly higher proportion of preterm birth in babies whose moms got the experimental RSV vaccine compared with those who got a placebo: 5.7% vs. 4.7%, respectively.
The difference between the groups was not statistically significant, meaning it could have been due to chance.”

About healthcare finance

At request of FTC, Amgen agrees to delay closure of $27.8B Horizon acquisition until September “Amgen has complied with an FTC request for a temporary restraining order, agreeing not to close its proposed $27.8 billion deal to acquire Horizon Therapeutics while the agency's lawsuit plays out.
The move comes in response to the FTC filing an antitrust lawsuit earlier this week which is attempting to block the sale.”

Today's News and Commentary

About health insurance/insurers

 2023 Medical Loss Ratio Rebates “We find that insurers estimate they will issue a total of about $1.1 billion in MLR rebates across all commercial markets in 2023…”

Senate passes resolution to overturn Biden administration rule that does not penalize immigrants for receiving government benefits “The Senate passed a resolution Wednesday to stop a Biden administration immigration rule that eliminates potential hurdles for immigrants using some public benefits and trying to obtain legal status, known as ‘public charge.’
It passed 50-47, with two Democratic senators crossing party lines – Joe Manchin of West Virginia and Jon Tester of Montana – both of whom are up for reelection.
The resolution is an effort to return to the Trump administration policy, which made it more difficult for immigrants to obtain legal status if they use public benefits.
It is a joint resolution, meaning it would need to pass in the House as well before it would reach President Joe Biden’s desk. The House has not yet voted on it.”
It is likely that the Biden administration would issue a veto if the resolution also passes in the House.”

About hospitals and healthcare systems

 Hospitals' revenues continue to decline due to increasing delays and denials by commercial insurers “Hospitals and health systems hoping to financially rebound from the pandemic-induced downturn have found themselves struggling to collect payments for services rendered, especially among commercial payors. A new Crowe report, "Time for a Commercial Break," analyzes information pulled by Crowe Revenue Cycle Analytics software and reveals when it comes to denial rates, accounts receivable, bad debt and takebacks, healthcare providers are having a much more favorable experience working with traditional Medicare over commercial insurers….
Traditional Medicare also fared better across prior authorization/precertification, initial and request for information (RFI) denial rates. Through the first quarter of 2023:

  • Initial prior authorization/precertification denial rate for inpatient claims for commercial payors was 3.2% compared with 0.2% for Medicare.

  • Commercial payors initially denied 15.1% of inpatient and outpatient claims for any reason compared with 3.9% for Medicare.

  • The RFI denial rate for inpatient and outpatient claims submitted by providers to commercial payors was 4.8%, 12 times Medicare's denial rate of 0.4%.”

About pharma

FTC expands probe into pharmacy benefit managers to GPOs “The Federal Trade Commission (FTC) is expanding its probe into pharmacy benefit managers by issuing compulsory orders to two group purchasing organizations that negotiate rebates on behalf of PBMs.
The FTC said late Wednesday that the orders will require Zinc Health Services and Ascent Health Services to provide key details and information on their business practices. Last summer, the agency sent similar orders to the six largest PBMs in the country: CVS Caremark, Express Scripts, Optum Rx, Humana Pharmacy Solutions, Prime Therapeutics and MedImpact Healthcare Systems.”

Supreme Court rules against Amgen in closely watched case over scope of patent claims “n a case that had the pharmaceutical industry on edge, the U.S. Supreme Court upheld a lower court ruling that Amgen failed to disclose sufficient information about patent claims for a best-selling drug.
The court ruled unanimously that Amgen failed to provide what amounts to a roadmap for others to recreate the claims made in two patents for Repatha, a cholesterol medication. A federal appeals court had previously invalidated the patents after deciding that Amgen filed an overly expansive patent claim that failed to disclose enough information so someone else can make the same product.”

Walgreens to pay San Francisco $230M for its role in opioid epidemic “Walgreens has agreed to pay $230 million to San Francisco for its role in the city’s opioid epidemic following last year’s landmark trial that found the pharmacy chain liable for not performing proper screenings.”

About health technology

New Biden science agency ARPA-H launches first program, targeting bone regrowth “The Advanced Research Projects Agency for Health, launched a little more than a year ago, announced Thursday that its first official program would target bone and joint damage from osteoarthritis, a condition affecting more than 32 million Americans.”

Today's News and Commentary

Exclusive: More Than 70% of Americans Feel Failed by the Health Care System “More than 70% of U.S. adults feel the health care system is failing to meet their needs in at least one way, according to new data from the Harris Poll, shared exclusively with TIME.
Affordability and “It takes too long to get an appointment” were major complaints. The graphics are very instructive.

About hospitals and healthcare systems

Kaiser Permanente discloses timeline, financial commitments for its VBC megadeal with Geisinger Health  FYI 

About pharma

Patterns of Manufacturer Coupon Use for Prescription Drugs in the US, 2017-2019 “In this cohort analysis of 35 352 individuals receiving pharmaceutical treatment for chronic diseases, nearly all of the first coupon use occurred with the first prescription fills. The frequency of manufacturer drug coupon use was associated with drugs operating in competitive environments but not with patient’s out-of-pocket costs or the characteristics of neighborhoods where the patients reside.” 

 Walgreens to pay San Francisco $230M for its role in opioid epidemic “Walgreens has agreed to pay $230 million to San Francisco for its role in the city’s opioid epidemic following last year’s landmark trial that found the pharmacy chain liable for not performing proper screenings.”

Drug Shortages Near an All-Time High, Leading to Rationing From The NY Times, a great review of the problems and its causes.

About the public’s health

 U.S. Depression Rates Reach New Highs “Over one-third of women (36.7%) now report having been diagnosed with depression at some point in their lifetime, compared with 20.4% of men, and their rate has risen at nearly twice the rate of men since 2017. Those aged 18 to 29 (34.3%) and 30 to 44 (34.9%) have significantly greater depression diagnosis rates in their lifetime than those older than 44.
Women (23.8%) and adults aged 18 to 29 (24.6%) also have the highest rates of current depression or treatment for depression. These two groups (up 6.2 and 11.6 percentage points, respectively), as well as adults aged 30 to 44, have the fastest-rising rates compared with 2017 estimates.
Lifetime depression rates are also climbing fast among Black and Hispanic adults and have now surpassed those of White respondents.”

2023 County Health Rankings National Findings Report Interactive report that allows you to search for a wealth of health-related data about your county.

About healthcare IT

VA renegotiates $10B Oracle Cerner EHR contract with stronger performance metrics, bigger penalties  After many years of false starts: “The Department of Veterans Affairs renegotiated its contract with Oracle Cerner to beef up accountability for tech glitches and patient safety issues with its beleaguered electronic health records project.
The renegotiated contract ‘dramatically increases’ VA’s ability to hold the technology company to account for the system’s performance, including reliability, responsiveness and interoperability, according to a statement from Dr. Neil Evans, the VA's acting program executive director for the Electronic Health Record Modernization project.”

About healthcare personnel

 Concern grows around US health-care workforce shortage: ‘We don’t have enough doctors’ “As of Monday, in areas where a health workforce shortage has been identified, the United States needs more than 17,000 additional primary care practitioners, 12,000 dental health practitioners and 8,200 mental health practitioners, according to data from the Health Resources & Services Administration. Those numbers are based on data that HRSA receives from state offices and health departments.”

About health technology

 Quick blood tests to spot cancer: will they help or harm patients? An excellent review of this topic from the Financial Times. Worthwhile if you can get a copy. 

Today's News and Commentary

About health insurance/insurers

Appeals court pauses Texas ruling against ACA preventive care coverage “The U.S. 5th Circuit Court of Appeals has temporarily blocked a Texas court's ruling earlier this year that struck down an ACA provision requiring payers and employers to provide coverage for preventive services.”

2023 EDITION High-cost claims and injectable drug trends analysis [From Sun Life] “Some key insights included in this year’s report are:
—71% of all stop-loss claims came from the top 10 conditions.
—While cancer continues to be the largest driver of high-cost claims, cardiovascular disease rose one spot to the #2 claim condition in 2022, with $142.4M in reimbursements for over 2,300 members.
—11 of the top 20 high-cost injectable drugs are related to the treatment of cancer.
—Rylaze, the cancer drug with the highest average cost ($808.7K), is new to the
top 20 injectables drug list this year.
—Approximately one in nine employers (11%) experienced a birth-related stop-loss claim in the four-year benefit period of 2018 through 2021. Newborn/infant care ranks at #5 in 2022, consistent with its previous ranking in the top five last year and has one of the highest average costs at $371.8K.
—20% of employers had at least one member with over $1M in claims during the four-year benefit period from 2018 through 2021.
—Million-dollar claims on a per million covered employees basis rose 15% in the past year and 45% over the past four year.”

About hospitals and healthcare systems

 30 most trusted healthcare brands When evaluating these lists, consider if they make sense. The facts that Mayo is #4 and Cleveland Clinic did not make the top 30 list is not believable.

 CommonSpirit reports $1.1B operating loss in 9-month period “Chicago-based CommonSpirit, one of the largest nonprofit health systems in the country, recorded operating losses of $658 million and $1.1 billion for the three- and nine-month periods ended March 31.
Those figures compared with operating losses of $591 million and $638 million for the same periods in the prior year. Lower contract labor costs helped stem some of the operating losses, although hiring challenges remain, the system said.
Improved investment returns also helped mitigate the overall loss..”

About pharma

 CVS closing down clinical trials business after 2 years “CVS Health is closing down its clinical trials arm just two years after its launch, a company spokesperson confirmed to Fierce Healthcare.
The spokesperson said the healthcare giant routinely reviews its portfolio to ensure its assets are ‘aligned with our long-term strategic priorities.’ The company will wind down Clinical Trial Services in "a phased way" and expects a full exit by Dec. 31, 2024.”

AstraZeneca is third member to leave PhRMA in five months “AstraZeneca has decided to leave the brand drug lobbying powerhouse PhRMA halfway through the year, the organization said.
The exit is the group’s third in five months, as AbbVie exited PhRMA in December and Teva Pharmaceuticals left in February.”
Comment: The company did not furnish a specific reason for the withdrawal.

About the public’s health

Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial “Among under-screened women from low-income backgrounds, mailed HPV self-collection kits with scheduling assistance led to greater uptake of cervical cancer screening than scheduling assistance alone. At-home HPV self-collection testing has the potential to increase screening uptake among under-screened women.” 

Black communities endured wave of excess deaths in past 2 decades, studies find “America’s Black communities experienced an excess 1.6 million deaths compared with the White population during the past two decades, a staggering loss that comes at a cost of hundreds of billions of dollars, according to two new studies that build on a generation of research into health disparities and inequity.
In one study, researchers conclude that the gap in health outcomes translated into 80 million years of potential life lost — years of life that could have been preserved if the gap between Black and White mortality rates had been eliminated. The second report determined the price society pays for failing to achieve health equity and allowing Black people to die prematurely: $238 billion in 2018 alone.”

World Health Organization Warns Against Using Artificial Sweeteners “The World Health Organization on Monday warned against using artificial sweeteners to control body weight or reduce the risk of noncommunicable diseases, saying that long-term use is not effective and could pose health risks.
These alternatives to sugar, when consumed long term, do not serve to reduce body fat in either adults or children, the W.H.O. said in a recommendation, adding that continued consumption could increase the risk of Type 2 diabetes, cardiovascular diseases and mortality in adults.”

About healthcare IT

 Google Cloud Launches AI-powered Solutions to Safely Accelerate Drug Discovery and Precision Medicine “Google Cloud announced two new AI-powered life sciences solutions to accelerate drug discovery and precision medicine for biotech companies, pharmaceutical firms, and public sector organizations. Available worldwide today, the Target and Lead Identification Suite helps researchers better identify the function of amino acids and predict the structure of proteins; and the Multiomics Suite accelerates the discovery and interpretation of genomic data, helping companies design precision treatments.”

About health technology

 Your DNA Can Now Be Pulled From Thin Air. Privacy Experts Are Worried. “Over the last decade, wildlife researchers have refined techniques for recovering environmental DNA, or eDNA — trace amounts of genetic material that all living things leave behind. A powerful and inexpensive tool for ecologists, eDNA is all over — floating in the air, or lingering in water, snow, honey and even your cup of tea. Researchers have used the method to detect invasive species before they take over, to track vulnerable or secretive wildlife populations and even to rediscover species thought to be extinct. The eDNA technology is also used in wastewater surveillance systems to monitor Covid and other pathogens.
But all along, scientists using eDNA were quietly recovering gobs and gobs of human DNA.”
Comment: Fascinating article in The NY Times. Read it if you can get access. Some questions that remain: who can use this DNA and for what purpose?

About healthcare finance

Trade commission fights Amgen's $28B purchase of Horizon Therapeutics “The Federal Trade Commission said on Tuesday it will try to block an effort by biopharmaceutical leader Amgen Inc. from purchasing Horizon Therapeutics for $28.3 billion, charging the move could force insurance companies to favor their products.
The FTC said the coupling of Amgen and Horizon could have allowed Amgen to leverage its portfolio of top-selling drugs to entrench a monopoly position in treatments for thyroid eye disease and chronic refractory gout.”

Scribe's CRISPR tech Prevails in new $1.5B biobucks deal with Lilly unit “Eli Lilly’s Prevail Therapeutics is jotting down up to $1.5 billion for Scribe Therapeutics in hopes of writing some new CRISPR-based genetic medicines for neurological and neuromuscular diseases into history.
Prevail, a wholly owned Lilly subsidiary developing genetic medicines for Parkinson’s disease and other neurodegenerative conditions, will also give California-based Scribe $75 million in an upfront payment and equity investment. Additionally, Prevail will provide R&D funding and pay Scribe certain royalties on future sales, offering the biotech more than $1.5 billion in milestone payments tied to the collaboration.
In return, Prevail gets exclusive rights to Scribe’s CRISPR X-Editing (XE) technologies to develop new in vivo therapies for certain targets known to cause serious neurological and neuromuscular diseases. Scribe will also have the chance to co-fund one program and share the profits for it in the U.S.”

Today's News and Commentary

About Covid-19

CDC sets first target for indoor air ventilation to prevent spread of Covid-19 “The US Centers for Disease Control and Prevention has extensively updated its ventilation guidance on helping prevent indoor transmission of the virus that causes Covid-19.
The agency had advised people to ventilate indoor air before, but this is the first time a federal agency has set a target – five air changes per hour – for how much rooms and buildings should be ventilated.”
Air quality experts cheered the updated recommendations.”

Getting to the Truth About the Effectiveness of Masks in Preventing COVID-19 The effectiveness of masking at the community level has been debated since the onset of the Covid-19 pandemic. The answers are not straightforward, but this editorial from the editors of the Annals of Internal Medicine is a great summary of what we know and how to interpret results.

About health insurance/insurers

 CMS redefines its definition of “Marketing” for Medicare Advantage plans and requires sign-off on materials. “…we are expanding our interpretation of the regulatory definition of ‘marketing’ to include content that mentions any type of benefit covered by the plan and is intended to draw a beneficiary's attention to plan or plans, influence a beneficiary's decision-making process when selecting a plan, or influence a beneficiary's decision to stay enrolled in a plan (that is, retention-based marketing) and thus subject to review.”

About pharma

 Estimated Annual Spending on Lecanemab and Its Ancillary Costs in the US Medicare Program “Lecanemab, an antidementia medication with modest clinical benefit, received accelerated US Food and Drug Administration (FDA) approval. Traditional FDA approval of lecanemab could occur in 2023, prompting Medicare to reconsider coverage restrictions and potentially enabling widespread use. Lecanemab’s $26 500 proposed annual acquisition cost and ancillary spending (eg, imaging) could increase Medicare spending, possibly leading to beneficiary premium increases…
If 85 687 (lower bound) eligible patients received lecanemab, Medicare would spend $2.0 billion annually (95% CI, $1.8-2.2 billion). If 216 536 (upper bound) eligible patients received lecanemab, Medicare would spend $5.1 billion annually (95% CI, $4.6-5.7 billion). Estimated annual per-patient coinsurance could reach $6636.”

New menopause drug for hot flashes gets FDA approval “The Food and Drug Administration approved the once-a-day pill from Astellas Pharma to treat moderate-to-severe symptoms, which can include sweating, flushing and chills.
Astellas’ drug, Veozah, uses a new approach, targeting brain connections that help control body temperature. The FDA said the medication will provide “an additional safe and effective treatment option for women,” in a statement.”

U.S. Supreme Court declines bid by Teva to hear ‘skinny labeling’ case with implications for generic drug access “After months of anticipation, the U.S. Supreme Court declined to hear an appeal of a lower court ruling that throws into question whether generic companies can ‘carve out’ uses for their medicines and supply Americans with cheaper alternatives to brand-name drugs.
At issue is skinny labeling, which happens when a generic company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.”

About the public’s health

FDA blocks marketing on 6,500 flavored e-cigarette products “The Food and Drug Administration on Friday blocked 10 companies from marketing or distributing 6,500 flavored e-liquid and e-cigarette products, part of its campaign against tobacco products being marketed to youths.
The agency said the product applications covered a variety of flavored e-cigarettes, including some with flavors such as Citrus and Strawberry Cheesecake, as well as Cool Mint and Menthol. The FDA said the companies in question did not provide sufficient evidence that marketing the products would be appropriate for public health.”

 About healthcare personnel

Envision files for bankruptcy: 6 details “Nashville, Tenn.-based Envision Healthcare has filed for Chapter 11 bankruptcy five years after New York City-based KKR & Co. acquired Envision in a $9.8 billion deal.”

 Federal government’s $1 billion effort to recruit next generation of doctors at risk “Over the last three years, millions of taxpayer dollars were pumped into the National Health Service Corps to hire thousands more doctors and nurses willing to serve the country’s most desperate regions during the COVID-19 pandemic in exchange for forgiving medical school debts. Now, with the health emergency over, the program’s expansion is in jeopardy – even as people struggle to get timely and quality care because of an industry-wide dearth of workers.
Funding for the program expires at the end of September, although President Joe Biden asked Congress to sign off an extra half-billion dollar for the project in his budget.”